In a randomized, double-blind controlled trial, 42 children with irritable bowel syndrome (IBS) were given pH-dependent, enteric-coated peppermint oil capsules or placebo. After 2 weeks, 75% of those receiving peppermint oil had reduced severity of pain associated with IBS. Peppermint oil may be used as a therapeutic agent during the symptomatic phase of IBS.

To determine the efficacy and tolerability of an enteric-coated peppermint-oil formulation (Colpermin), we conducted a prospective, randomized, double-blind, placebo-controlled clinical study in 110 outpatients (66 men/44 women; 18-70 years of age) with symptoms of irritable bowel syndrome. Patients took one capsule (Colpermin or placebo) three to four times daily, 15-30 min before meals, for 1 month. Fifty-two patients on Colpermin and 49 on placebo completed the study. Forty-one patients on Colpermin (79%) experienced an alleviation of the severity of abdominal pain (29 were pain-free); 43 (83%) had less abdominal distension, 43 (83%) had reduced stool frequency, 38 (73%) had fewer borborygmi, and 41 (79%) less flatulence. Corresponding figures for the placebo group were: 21 patients (43%) with reduced pain (4 were pain-free), 14 (29%) with reduced distension, 16 (32%) with reduced stool frequency, 15 (31%) with fewer borborygmi, and 11 (22%) with less flatulence. Symptom improvements after Colpermin were significantly better than after placebo (P < 0.05; Mann-Whitney U-test). One patient on Colpermin experienced heartburn (because of chewing the capsules) and one developed a mild transient skin rash. There were no significant changes in liver function test results. Thus, in this trial, Colpermin was effective and well tolerated.

OBJECTIVE: To determine the effectiveness of ginger for the treatment of nausea and vomiting of pregnancy. METHODS: Women with nausea and vomiting of pregnancy, who first attended an antenatal clinic at or before 17 weeks' gestation, were invited to participate in the study. During a 5-month period, 70 eligible women gave consent and were randomized in a double-masked design to receive either oral ginger 1 g per day or an identical placebo for 4 days. Subjects graded the severity of their nausea using visual analog scales and recorded the number of vomiting episodes in the previous 24 hours before treatment, and again during 4 consecutive days while taking treatment. At a follow-up visit 7 days later, five-item Likert scales were used to assess the severity of their symptoms. RESULTS: All participants except three in the placebo group remained in the study. The visual analog scores of posttherapy minus baseline nausea decreased significantly in the ginger group (2.1 +/- 1.9) compared with the placebo group (0.9 +/- 2.2, P =.014). The number of vomiting episodes also decreased significantly in the ginger group (1.4 +/- 1.3) compared with the placebo group (0.3 +/- 1.1, P <.001). Likert scales showed that 28 of 32 in the ginger group had improvement in nausea symptoms compared with 10 of 35 in the placebo group (P <.001). No adverse effect of ginger on pregnancy outcome was detected. CONCLUSION: Ginger is effective for relieving the severity of nausea and vomiting of pregnancy.

BACKGROUND: Irritable bowel syndrome (IBS) is a widespread functional disorder of the digestive tract. Its aetiology is unknown and therapeutic options are limited. Recent reports suggest that probiotics may have a role in regulating the motility of the digestive tract. AIM: To assess the efficacy of Lactobacillus plantarum 299V (LP299V) in patients with IBS. PATIENTS AND METHODS: Forty patients were randomized to receive either LP299V in liquid suspension (20 patients) or placebo (20 patients) over a period of 4 weeks. Clinical examination was performed at baseline and at the end of the study. Additionally, patients assessed their symptoms by applying a scoring system. RESULTS: All patients treated with LP299V reported resolution of their abdominal pain as compared to 11 patients from a placebo group (P = 0.0012). There was also a trend towards normalization of stools frequency in constipated patients in six out of 10 patients treated with LP299V compared with two out of 11 treated with placebo (P = 0.17). With regards to all IBS symptoms an improvement was noted in 95% of patients in the LP299V group vs 15% of patients in the placebo group (P < 0.0001). CONCLUSIONS: LP299V seems to have a beneficial effect in patients with IBS. Further studies on larger cohorts of patients and with longer duration of therapy are required in order to establish the place of L. plantarum in the treatment of IBS.

OBJECTIVE: The influence of the gastrointestinal (GI) microflora in patients with irritable bowel syndrome (IBS) has not been clearly elucidated. This study was undertaken to see if patients with IBS have an imbalance in their normal colonic flora, as some bacterial taxa are more prone to gas production than others. We also wanted to study whether the flora could be altered by exogenous supplementation. In a previous study we have characterized the mucosa-associated lactobacilli in healthy individuals and found some strains with good colonizing ability. Upon colonization, they seemed to reduce gas formation. METHODS: The study comprised 60 patients with IBS and a normal colonoscopy or barium enema. Patients fulfilling the Rome criteria, without a history of malabsorption, and with normal blood tests underwent a sigmoidoscopy with biopsy. They were randomized into two groups, one receiving 400 ml per day of a rose-hip drink containing 5 x 10(7) cfu/ml of Lactobacillus plantarum (DSM 9843) and 0.009 g/ml oat flour, and the other group receiving a plain rose-hip drink, comparable in color, texture, and taste. The administration lasted for 4 wk. The patients recorded their own GI function, starting 2 wk before the study and continuing throughout the study period. Twelve months after the end of the study all patients were asked to complete the same questionnaire regarding their symptomatology as at the start of the study. RESULTS: All patients tolerated the products well. The patients receiving Lb. plantarum had these bacteria on rectal biopsies. There were no major changes of Enterobacteriaceae in either group, before or after the study, but the Enterococci increased in the placebo group and remained unchanged in the test group. Flatulence was rapidly and significantly reduced in the test group compared with the placebo group (number of days with abundant gas production, test group 6.5 before, 3.1 after vs 7.4 before and 5.6 after for the placebo group). Abdominal pain was reduced in both groups. At the 12-month follow-up, patients in the test group maintained a better overall GI function than control patients. There was no difference between the groups regarding bloating. Fifty-nine percent of the test group patients had a continuous intake of fermented products, whereas the corresponding figure for the control patients was 73%. CONCLUSIONS: The results of the study indicate that the administration of Lb. plantarum with known probiotic properties decreased pain and flatulence in patients with IBS. The fiber content of the test solution was minimal and it is unlikely that the fiber content could have had any effect. This type of probiotic therapy warrants further studies in IBS patients.

Efficacy of ginger for nausea and vomiting: a systematic review of randomized clinical trials.

Ernst E, Pittler MH.

Department of Complementary Medicine, School of Postgraduate Medicine and Health Sciences, University of Exeter, UK.

Ginger (Zingiber officinale) is often advocated as beneficial for nausea and vomiting. Whether the herb is truly efficacious for this condition is, however, still a matter of debate. We have performed a systematic review of the evidence from randomized controlled trials for or against the efficacy of ginger for nausea and vomiting. Six studies met all inclusion criteria and were reviewed. Three on postoperative nausea and vomiting were identified and two of these suggested that ginger was superior to placebo and equally effective as metoclopramide. The pooled absolute risk reduction for the incidence of postoperative nausea, however, indicated a non-significant difference between the ginger and placebo groups for ginger 1 g taken before operation (absolute risk reduction 0.052 (95% confidence interval -0.082 to 0.186)). One study was found for each of the following conditions: seasickness, morning sickness and chemotherapy-induced nausea. These studies collectively favoured ginger over placebo.

Ginger is well known in the form of ginger sticks or ginger ale. If these are consumed during travel, the traveler imbibes, albeit subconsciously, a healing plant for motion sickness. The efficacy of ginger rhizome for the prevention of nausea, dizziness, and vomiting as symptoms of motion sickness (kinetosis), as well as for postoperative vomiting and vomiting of pregnancy, has been well documented and proved beyond doubt in numerous high-quality clinical studies. The use of this ancient medicine for gastrointestinal problems (stimulation of digestion) has been given scientific approval. Today, medicinal ginger is used mainly for prevention of the symptoms of travel sickness.

May 21, 2003 (Orlando) — Probiotic therapy, primarily in the form of Lactobacillus acidophilus and Bifidobacteria infantis, significantly improves symptoms and quality of life in patients with irritable bowel syndrome (IBS) and other bowel disorders, researchers reported in a number of presentations here at Digestive Disease Week 2003.

In a study designed to assess the efficacy of probiotics alone or in combination with antibiotics in patients with IBS, Stephen M. Faber, MD, from Albemarle Gastroenterology Associates, PC, in Elizabeth City, North Carolina, evaluated treatment in 44 patients with IBS. Twenty patients received probiotics alone and 24 received ciprofloxacin 500 mg twice daily for one week and two probiotic formulations, Lactobacillus (NCFM) 10 billion/g and Bifidobacteia infantis (Bifdo), 10 billion/g for four weeks.

Patients completed the IBS-Quality of Life (IBS-QOL) questionnaire and the Symptom Frequency Index (SFI) before and after treatment. For the study group as a whole, IBS-QOL scores averaged 66.2 before treatment and 84.6 after treatment. SFI scores before treatment averaged 38, decreasing to 18 after treatment.

In patients who received both probiotics and antibiotics, IBS-QOL scores averaged 67.6 before and 87.8 after treatment. SFI scores averaged 35 at baseline, decreasing to 18 after treatment.

In the probiotic-only group, baseline IBS-QOL scores were 69.3, increasing to 86.4 after treatment. SFI scores were 39 at baseline and 17 after treatment.

A retrospective look at IBS patients treated with probiotics indicates that there is a deficiency of Lactobacillus in the gut flora in patients with IBS, Dr. Faber noted, "but we're not ready to call IBS an infectious disease."

Probiotic therapy also improved symptoms of ulcerative colitis (UC) in a separate study presented by Richard N. Fedorak, MD, professor of medicine and director of the division of gastroenterology at the University of Alberta in Edmonton, Canada.

In a safety and efficacy study of the probiotic formulation VSL3 (VSL Pharmaceuticals, Inc., Ft. Lauderdale, FL), which contains eight lactic acid bacterial species, Dr. Fedorak and colleagues evaluated 30 patients with active mild-to-moderate UC with recent flares. Patients continued with previous treatment that included mesalamine, corticosteroids, and/or azathiaprine, as long as the treatment regimen was stable prior to the study.

Patients took two VSL3 sachets twice a day for six weeks. Ulcerative Colitis Clinical Scores were measured and sigmoidoscopy performed at baseline and after the six-week treatment period.

Dr. Fedorak reported that remission occurred in 63% (19 patients) and there was a clinical response in an additional 23% (seven patients). There was no response in 13% (four patients). Worsening of symptoms occurred in one patient.

Dr. Fedorak said that probiotic therapy was not associated with any adverse clinical or biochemical events.

"I haven't heard of getting into trouble with probiotics," Dr. Faber told Medscape. "These are organisms that are supposed to be in the gut. The body knows how to control them, so it doesn't seem that you can overtreat."

While probiotics have been recognized as beneficial components of food, Dr. Fedorak pointed out that "we don't use it as a food product anymore but as a treatment.

"Infantile diarrhea can be shortened by about a day from the usual three- to four-day course. That is very important in infants. Probiotics are effective with rotavirus symptoms, with antibiotic-induced diarrhea, in pseudomembranous colitis, and perhaps in radiation-induced diarrhea," he said.

But Dr. Fedorak cautioned that "we don't know how they work. They appear to strengthen the mucosal barrier of the bowel and improve immune function. And we don't know which probiotics to use or in what combination."

CONTEXT: Despite its benign, natural course, colic is a significant problem in infants and imparts a psychological, emotional, and physical burden to parents. Dicyclomine hydrochloride is the only pharmacological treatment for infantile colic that has been consistently effective. Unfortunately, 5% of infants treated with dicyclomine hydrochloride develop serious side effects, including death. Fennel seed oil has been shown to reduce intestinal spasms and increase motility of the small intestine. However, there have not been any clinical studies of its effectiveness. OBJECTIVES: To determine the effectiveness of fennel seed oil emulsion in infantile colic. DESIGN: Randomized placebo-controlled trial. SETTINGS: Two large multi-specialty clinics. SUBJECTS: 125 infants, 2 to 12 weeks of age, who met definition of colic. INTERVENTION: Fennel seed oil emulsion compared with placebo. OUTCOME MEASURE: Relief of colic symptoms, which was defined as decrease of cumulative crying to less than 9 hours per week. RESULTS: The use of fennel oil emulsion eliminated colic, according to the Wessel criteria, in 65% (40/62) of infants in the treatment group, which was significantly better than 23.7% (14/59) of infants in the control group (P < 0.01). There was a significant improvement of colic in the treatment group compared with the control group [Absolute Risk Reduction (ARR) = 41% (95% CI 25 to 57), Number Needed to Treat (NNT) = 2 (95% CI 2 to 4)]. Side effects were not reported for infants in either group during the trial. CONCLUSION: Our study suggests that fennel seed oil emulsion is superior to placebo in decreasing intensity of infantile colic.

Comparison of fennel and mefenamic acid for the treatment of primary dysmenorrhea.

Namavar Jahromi B, Tartifizadeh A, Khabnadideh S.

Department of Obstetrics and Gynecology, Shiraz University of Medical Sciences, Shiraz, Iran.

OBJECTIVES: To compare the effect of Foeniculum vulgare variety dulce (Sweet Fennel) vs. mefenamic acid for the treatment of primary dysmenorrhea. METHODS: A cohort of seventy women, 15-24 years old from a local university and high-school, who complained of dysmenorrhea were enrolled in this study. Ten cases were excluded due to evidence of secondary dysmenorrhea. The remaining 60 patients were graded mild, moderate and severe on the basis of a verbal multidimensional scoring system. Thirty patients with mild dysmenorrhea were also excluded from the study. Each of the 30 cases with moderate to severe dysmenorrhea was evaluated for three cycles. In the first cycle no medication was given (control cycle), in the second cycle the cases were treated by mefenamic acid (250 mg q6h orally) and in the third cycle, essence of Fennel's fruit with 2% concentration (25 drops q4h orally), was prescribed at the beginning of the cycle. These cycles were compared day by day for the effect, potency, time of initiation of action and also complications associated with each treatment modality, by using a self-scoring system. Intensity of pain was reported by using a 10-point linear analog technique. Statistical analyses were performed by the independent sample t-test, paired t-test and repeated measurement analysis method. RESULTS: In the study group the mean age of menarche was 12.5+/-1.3 years, the mean duration of menstruation was 6.6+/-1.4 days with the mean cycle days of 27+/-3. The findings observed during menses were as follows: headache in 26.7%, nausea in 63.3%, vomiting in 23.3%, diarrhea in 33.3%, fatigue in 93.3% and leaving the daily tasks undone was reported in 86.9% of the cases. Both of the drugs effectively relieved menstrual pain as compared with the control cycles (P<0.001). The mean duration of initiation of action was 67.5+/-46.06 min for mefenamic acid and 75+/-48.9 min for fennel. The difference was not statistically significant (P=0.57). Mefenamic acid had a more potent effect than fennel on the second and third menstrual days (P<0.05), however, the difference on the other days was not significant. No complication was reported in mefenamic acid treated cycles, but one case (3.11%) reported a mild increase in the amount of her menstrual flow. CONCLUSIONS: The essence of fennel can be used as a safe and effective herbal drug for primary dysmenorrhea, however, it may have a lower potency than mefenamic acid in the dosages used for this study.

Hepatoprotective activity of Foeniculum vulgare (fennel) essential oil (FEO) was studied using carbon tetrachloride (CCl(4)) induced liver injury model in rats. The hepatotoxicity produced by acute CCl(4) administration was found to be inhibited by FEO with evidence of decreased levels of serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) and bilirubin. The results of this study indicate that FEO has a potent hepatoprotective action against CCl(4)-induced hepatic damage in rats.

If you are currently being treated with any of the following medications, you should not use ginger without first talking to your healthcare provider.

Blood-thinning medicationsAlthough ginger may interfere with blood clotting, there have been no scientific or case reports of interactions between ginger and blood-thinning medications. However, people taking these medications with ginger should be monitored closely by a healthcare practitioner for risk of bleeding.

CyclophosphamideGinger may reduce the toxic side effects of cyclophosphamide (a medication used to treat a variety of cancers). More research is needed in this area.

BACKGROUND: The aim of the present study was to investigate the effect of a probiotic beverage on gastrointestinal symptoms in patients with chronic constipation.

METHODS: A double-blind, placebo-controlled, randomized study was conducted over a four-week period in patients with symptoms of chronic constipation (n=70). To all patients, 65 mL/day of a probiotic beverage containing Lactobacillus casei Shirota (LcS) or a sensorially identical placebo was administered. Patients completed a questionnaire on gastrointestinal symptoms, well-being and stool habits and underwent a medical examination weekly. Severity of constipation, flatulence and bloating was summarized into four categories (severe, moderately severe, mild and no symptoms).

RESULTS: The consumption of LcS resulted in a significant improvement in self-reported severity of constipation and stool consistency, starting in the second week of the intervention phase (P<0.0001). Severe and moderately severe constipation was observed less in the LcS group. The occurrence and degree of flatulence or bloating sensation did not change. In the final examination, 89% of the LcS group and 56% of the placebo group showed a positive effect of their beverage on constipation (P=0.003). No adverse reactions were reported.

CONCLUSIONS: The results indicate a beneficial effect on gastrointestinal symptoms of patients with chronic constipation. The administration of probiotic foodstuffs may be recommended as an adjunctive therapy of chronic constipation.

Swedish researchers from Lund University in Lund note that lactic acid fermentation is the simplest and safest way to preserve food. They suggest that people have likely always used it in food preservation.

Various species, such as L plantarum, L rhamnosus, L paracasei, L acidophilus and L salivarius, occur in human mucosa from the mouth to the rectum.

Investigators point out that L plantarum is found in foods that are fermented from plants, while L paracasei and L rhamnosus are associated with dairy products.

They explain that L plantarum 299v is a strain originating from the human intestinal mucosa. Animal research has shown that it decreases translocation and improves mucosal and liver status. It also improves the immunological status of mucosa and reduces mucosal inflammation.

In people, L plantarum 299v increases the concentration of carboxylic acids in feces and decreases abdominal bloating in patients with IBS. It can also decrease fibrinogen concentrations in the blood.

Investigators note that a probiotic food product that contains no milk constituent was launched in Sweden in 1994. This product -- a lactic acid-fermented oatmeal gruel mixed with a fruit drink -- contains approximately 5 x 10(10) colony-forming units of L plantarum 299v.

"Should probiotics be administered through foods," the researchers point out, "the probiotic organism must remain vigorous in the food until consumption, and the food must remain palatable."

They add that L plantarum 299v affects both the bacterial flora of the intestinal mucosa and regulates the host's immunologic defence. American Journal of Clinical Nutrition, 2001; 73: 380S-385S

Battling my way around the supermarket aisles, bamboozled by the array of new products on the shelves, I am suddenly aware of an invasive life form taking hold of the chiller cabinet. Having turned yoghurts into drinks, the marketing men have decided to woo us with science, by plastering the word "probiotic" on the pots.

The blurb tells us that they are good for us; that they aid digestive health; and that they give our guts that most elusive elixir of 21st century life - balance.

But if you don’t have time to peruse the fine print on those little bottles of Yakult, Danone Actimel et al, you may have walked on by to the check-out simply because you don’t know what a probiotic is.

Even if you do, you may well be wondering how much scientific evidence exists to back the manufacturers’ claims that they are good for your health.

Probiotics - which means "for life" - are so-called "friendly bacteria" which are believed to be beneficial in maintaining a healthy digestive system.

The human gut is home to around 400 different species of bugs, some good, and some bad. The Lactobacillus and Bifidobacterium lurking there are probiotic species of bugs which aid digestion by breaking down tough fibres, enzymes and other proteins in our food. Probiotics also produce important nutrients such as vitamin K, and ferment organic acids which are absorbed into the bloodstream for energy.

However, these good guys have to share their habitat with bad bugs such as E.Coli, Salmonella and Clostridium - bugs which are responsible for most bouts of diarrhoea, and which can prove fatal.

The balance between the good and bad bacteria is key to maintaining good digestive health, and when all is well our digestive systems are a relatively stable "microflora".

So if probiotics are already part of the body’s natural make-up, why pay to throw even more of them down our throats? The answer to that lies in the daily assaults our digestive system receives from what we consume, and the way we live.

Stress, illness and prescription medicines can all play havoc with the bacterial balance. Antibiotics pose particular problems, because as well as killing off the bad bacteria for which they were prescribed, they kill off the good guys too.

It is in a bid to restore balance - or guard against imbalance - that most people turn to probiotic products.

Probiotics certainly have an army of fans, with the worldwide markets for products such as Yakult, Danone, Actimel and the like estimated to stand at £3.3 billion a year.

Over the past century or so probiotics have been credited with alleviating symptoms in a range of illnesses, from constipation and irritable bowel syndrome, to more serious gut complaints such as ulcerative colitis and Crohn’s disease. They have also been applied in the treatment of vaginal, urinary tract, dental, ear and wound infections. In addition, they have been shown to reduce the length of illness in some of the 100,000 cases of food poisoning seen in the UK annually due to pathogen - or disease causing - bacteria.

But how big is the body of scientific evidence that probiotics actually work?

Probiotics have had almost a century to prove themselves. The concept first emerged in 1907, when Elie Metchnikoff, the Nobel Prize winning scientist, attributed the longevity of a Bulgarian peasant village to its inhabitants’ consumption of live yoghurt. Metchnikoff’s work influenced a Japanese doctor, Minoru Shirota, who in 1935 developed a fermented milk drink containing the unique probiotic, Lactobacillus casei shirota. Shirota claimed this bacteria was beneficial, and named it Yakult - the Esperanto word for yoghurt. The probiotic drink was born.

Since then a number of well designed clinical trials have shown beneficial effects of probiotics in the treatment of travellers’ diarrhoea, acute diarrhoea in children and antibiotic associated diarrhoea. Other trials have also shown that lactobacilli taken as live yoghurt or vaginal tablets can successfully treat vaginal bacterial and Candida infections. One Canadian research team has had some success in using intravaginal probiotics to treat recurrent urinary tract infections. Trials also suggest that such bacteria can have a beneficial effect on the immune system.

One Finnish study found that giving a daily dose of the probiotic Lactobacillus rhamnosus bacteria to pregnant women and their babies during the first six months of life reduced the incidence of eczema, when compared with a control group which did not receive the bacteria.

The Bifidobacteria which are present in breast milk, are also known to rapidly colonise the guts of breast-fed babies, who suffer fewer gastrointestinal infections as a result. Scientists are now wondering if probiotics could play a part in the immunisation of babies, and if it would be beneficial to add probiotic substances to infant milk formulas.

A similar approach is already being used by the United States Agricultural Research Service to reduce levels of disease-causing bacteria such as Salmonella and Campylobacter in poultry. Newly hatched birds are fed probiotic bacteria to prevent their guts being colonised with bacteria, which have the potential to cause food-borne illness in humans.

Professor Tom MacDonald, a gut immunologist at Southampton University, is currently looking at various aspects of immune function in healthy individuals taking the probiotic drink Actimel.

He says that the scientific community is very interested in the use of probiotics in treating inflammatory bowel diseases such as ulcerative colitis and crohn’s, but says there is a paucity of good clinical trials in this area.

Professor George MacFarlane, a bacteriologist at the Medical Research Council Microbiology and Gut Biology Unit at Ninewells Hospital in Dundee, may have found a way to make the "probiotic hit" more effective. Researchers recently completed a pilot study in ulcerative colitis of a "synbiotic" - a prebiotic given in combination with a probiotic - which he says gives the probiotic a better opportunity to establish itself in the bowel.

"We found that there were differences in the populations of Bifidobacteria in the gut lining of healthy people compared with ulcerative colitis patients. We then selected a Bifidobacterium from a healthy mucosa [gut lining] and looked to see whether it had probiotic qualities and whether it grew well on the probiotic," he says. Colitis patients were given the synbiotic for a month in a double-blind placebo-controlled trial. The results are yet to be published, but Prof MacFarlane says it found marked improvements in clinical appearance and reduced inflammation.

Considering the apparent benefits of probiotics, they were slow to arrive in the UK. Yakult launched in Japan in 1955, but it only started manufacturing in Europe in 1994 and did not reach the UK until 1996. Danone launched its probiotic drink Actimel in Belgium in 1994, and it now sells in 26 countries, with an estimated 6 million bottles being consumed daily. Danone claims its patented probiotic, Lactobacillus.casei.immunitass, "helps support your body’s natural defences". Muller introduced their probiotic, Provitality, range in 2000. Probiotic products seem to be proliferating faster than a bacterial culture.

But if research has been lacking in some areas, that seems about to change. Although technically rivals, Danone and Yakult recently announced that they are to collaborate more closely on the development of probiotic products. The EU recently invested more than 15 million on research in this area, and a forthcoming directive on food labelling may allow probiotic products to carry wider claims about their health benefits.

But what does all this mean when you are doing your supermarket shop? Should you go probiotic? And if so, how much should you consume, and how often? Scientists point out that the intestinal microflora is carefully balanced, and therefore it is difficult for invading bacteria to gain a foothold - and that goes for probiotic strains too. For that reason, it is generally recommended that probiotics are taken on a daily basis.

Professor Colette Shortt, director of science at Yakult, says: "We carried out a study of healthy individuals in the Netherlands, and that showed that there were increased levels of the actual probiotic strain. However, after seven days or so the levels of bacteria fall. So there is only a transient colonisation. The probiotics have to be ingested regularly to maintain levels." Results which are sure to maintain sales.

If probiotics attract you, but those pale liquids don’t, check out health food shops for capsule forms - or try prebiotic tablets which aim to selectively stimulate the growth of good bacteria.

The Food Standards Agency in England is due to publish the results of two surveys shortly, one on the persistence of probiotics in the lower bowel, the other on the labelling of probiotic foodstuffs and supplements. The results should pave the way for tighter regulation of health claims on all foodstuffs - including probiotics - and so make it easier for consumers to make informed choices.

Meanwhile, the gut feeling among experts seems to be that consumption of probiotics may have health benefits for us all. Professor MacDonald says: "They certainly don’t do any harm. And compared with other things we put in our mouths, probiotics are not so bad."

The authors do not specify the brand or type of yogurt, but note that manufacturer-supplied nutritional data indicated that the product contained active cultures of Lactobacillus acidophilus, Lactobacillus bulgaricus, and Streptococcus thermophilus. The mean age of the study participants was 70 years. All of the patients were followed for a total of eight days. Persons assessing outcomes were not blinded to treatment group assignment. Antibiotic-associated diarrhea was defined as the new onset of more than two less-than-formed bowel movements per day representing a change in previous bowel patterns.

Using intention-to-treat analysis, the authors found that patients receiving yogurt reported less frequent diarrhea (12 versus 24 percent in the usual care group; P = .04; number needed to treat = 12). In addition, patients ingesting yogurt daily reported significantly fewer days with diarrhea (23 versus 60 days). No side effects were reported other than boredom: yogurt-fed patients yearned for fruit-flavored yogurt to break the monotony.

Purpose of review: This review summarizes the clinical efficacy of probiotics and prebiotics in gastrointestinal disorders and examines the mechanisms of action related to their therapeutic effect.

Recent findings: The demonstration that immune and epithelial cells can discriminate between different microbial species has extended the known mechanism(s) of action of probiotics beyond simple barrier and antimicrobial effects. It has also confirmed that probiotic bacteria modulate mucosal and systemic immune activity and epithelial function. The progressive unraveling of these mechanisms of action has led to new credence for the use of probiotics and prebiotics in clinical medicine. Level I evidence now exists for the therapeutic use of probiotics in infectious diarrhea in children, recurrent Clostridium difficile-induced infections and postoperative pouchitis. Level II evidence is emerging for the use of probiotics in other gastrointestinal infections, prevention of postoperative bacterial translocation, irritable bowel syndrome, and in both ulcerative colitis and Crohn disease. Nevertheless, one consistent feature has emerged over the past year: Not all probiotic bacteria have similar therapeutic effects. Future clinical trials will need to incorporate this fact into trial planning and design.

Summary: The use of probiotics and prebiotics as therapeutic agents for gastrointestinal disorders is rapidly moving into the mainstream. Mechanisms of action explain the therapeutic effects and randomized; controlled trials provide the necessary evidence for their incorporation into the therapeutic armamentarium.

New York and London are famous for both their congestion and the diverse origins of their residents. But if you're looking for the ultimate teeming metropolis of immigrants, check out the large intestine. In people, some 500 to 1,000 kinds of bacteria reside in this part of the gastrointestinal (GI) tract, and these gut microbes outnumber all the cells in your body, perhaps by as much as a factor of 10.

"The density of this society is mind-boggling," says Jeffrey I. Gordon of Washington University School of Medicine in St. Louis.

It's a society overlooked by most microbiologists, who generally stick to the myriad bacteria that cause disease. Yet some scientists argue that it's shortsighted to ignore what they call the microflora living in our intestines.

"What these bacteria do definitely makes a very significant contribution to our health—or lack thereof," says Mark Schell of the University of Georgia in Athens, who studies an intestinal microbe called Bifodobacterium longum.

Shell and a few other researchers have recently begun to probe exactly what individual microbes do for or to the intestine.

Consider Bacteriodes thetaiotaomicron. Although not as well known, it's more than 1,000 times as abundant in the guts of people and mice as the extensively studied bacterium Escherichia coli. Some researchers have proposed that in return for a steady food supply, B. thetaiotaomicron breaks down indigestible complex carbohydrates into easily absorbed sugars and produces other substances, such as vitamins, that benefit its host.

There may be much more to this microbe-host relationship, however. About a decade ago, Gordon chose B. thetaiotaomicron as a prototypical germ for studying how microbes influence the GI tract. This bacterium normally becomes a predominant member of the intestinal community about the time an animal is weaned from its mother's milk. Gordon's research team has discovered that the microbe can turn on specific intestinal genes, promote the growth of blood vessels necessary for the gut's function, and trigger production of a chemical that may kill competing bacteria. Investigators are now asking just how much gut bacteria regulate the developing and adult human body.

"Bacteria do an awful lot for us and with us," says Gordon. "Most people's views of bacteria are of menacing, disease-promoting entities. Au contraire, I think that most of our encounters with bacteria are mutually beneficial, friendly, and part of our normal biology. . . . They've insinuated themselves into our biology and coevolved with us."

Sweet-talking germ

Perhaps the best way to understand the significance of intestinal microorganisms is to see what happens when an animal doesn't have them. During the past 50 years, researchers have created germfree mice and rats by delivering the animals by cesarean section into sterile environments and maintaining them there. "It's a very demanding technology," says Gordon. Scientists have generally used such germfree animals to study how particular pathogens cause diseases.

One of the most striking aspects of a germfree rodent is that it must consume about 30 percent more calories to maintain its body weight than a typical rodent does. Germfree animals are also unusually susceptible to infections, presumably because the microflora in a normal gut ward off foreign pathogens.

As a way to study animals hosting a simplified society of gut bacteria, Gordon and his colleagues have introduced B. thetaiotaomicron into germfree mice. Their first significant discovery was that the bacterium could change what sugars the intestine makes.

The surfaces of intestinal cells of typical mice are coated with complex sugars containing the simple sugar fucose and B. thetaiotaomicron consumes the fucose for energy. In germfree mice, however, fucose production ceases around the time of weaning.

If B. thetaiotaomicron colonizes a germfree mouse before weaning, however, normal fucose synthesis continues throughout life, the researchers found. Through a still undiscovered signal, the microbe apparently induces the intestinal cells to make one of its favorite foods. The bacterium even has a fucose sensor that informs it when this food source is scarce, according to Gordon and his colleagues.

The capacity of B. thetaiotaomicron to instruct intestinal cells to make fucose was just a hint of things to come. To get a more comprehensive picture of the bacterium's influence, Gordon's group turned to microchip-size devices, called DNA microarrays, that monitor the activity of thousands of genes at once (SN: 3/8/97, p. 144).

With such instruments, the scientists took a snapshot of the gene activity in the mouse intestine. By comparing tissue from germfree mice and mice hosting B. thetaiotaomicron, the team found that the presence of the bacterium significantly reduces or boosts the activity of about 100 of the approximately 25,000 rodent genes in the microarray survey.

Some of the intestinal genes triggered by the microbe help mammals absorb and metabolize sugars and fats, Gordon and his colleagues reported in 2001. Other activated genes fortify the cellular barrier that prevents bacteria, both dangerous and friendly, from sneaking out of the intestine into other tissues and the bloodstream. And yet other affected genes determine how the intestine detoxifies compounds and how the gut matures.

"We were amazed at the breadth of normal intestinal functions affected by a single microbe," says study coauthor Lora V. Hopper. Gordon adds, "It's difficult to anticipate the full range of host functions that might be manipulated by these microbes."

The genetic activity that the researchers didn't see in the bacteria-colonized mice was interesting, too. Even though the originally germfree mice had never encountered B. thetaiotaomicron before, there was no increase in activity of the genes underlying an immune or inflammatory response. That's a reflection of the microbe's still mysterious skill at convincing a host that it's a friendly visitor and not a danger, says Gordon.

Raising fences

Among the intestinal genes activated by B. thetaiotaomicron is one suspected to stimulate the growth of new blood vessels. The finding spurred Gordon's group to investigate the microbe's control over the system of blood vessels that runs through the GI tract. These blood vessels are crucial to a body's absorption of nutrients.

The researchers discovered that their germfree mice have a poorly formed network of the capillaries that normally supply the inner intestinal surface with its blood supply. This could partly explain the difficulty that germfree animals have absorbing nutrients.

The team also found that it could stimulate germfree mice to grow a normal network of intestinal capillaries by exposing the animals to either a full complement of microflora or just B. thetaiotaomicron. The investigators reported the finding in the Nov. 26, 2002 Proceedings of the National Academy of Sciences.

This is a vivid illustration that the physical development of the gut can depend on the microbes that normally inhabit animals, says Gordon. The researchers also found cells in the mouse gut that seems to work with the microbes to spur vessel growth.

In the small intestine, so-called Paneth cells normally secrete antimicrobial compounds (SN: 8/26/00, p. 135: Available to subscribers at http://www.sciencenews.org/20000826/fob8.asp). This keeps the intestine healthy by protecting other cells that continually replenish the gut lining. Gordon's team created germfree versions of mutant mice that lack Paneth cells and found that B. thetaiotaomicron couldn't trigger the maturation of blood vessels in such rodents. While most investigators have regarded Paneth cells simply as defenders against invading bacteria, it makes sense that these cells mediate interactions between a host and its natural microflora, says Gordon. "What better cell to respond to the presence or absence of a microbe?" he remarks.

The Paneth cell is at the heart of another microbe-intestine interaction uncovered recently by Gordon's group. One of the intestinal genes triggered in germfree mice by B. thetaiotaomicron encodes a protein called angiogenin 4 or Ang4. Cancer researchers are particularly interested in this protein, because they have evidence that it nourishes tumors by creating new blood vessels. Gordon's team suspected that Ang4 plays a role in the intestinal blood vessel maturation that they had documented earlier. Indeed, it turned out that Paneth cells make Ang4 and secrete it when they detect bacteria.

While the suspicion that Ang4 makes intestinal blood vessels has not yet been proven, it looks like the protein has a more certain role. It can kill several bacteria and fungi that cause diseases in mammals, Gordon, Hooper, and their colleagues report in the March Nature Immunology. In contrast, B. thetaiotaomicron and other common residents of the mouse intestines are largely resistant to Ang4.

"One interpretation of the interaction between host defense and the resident flora is that the resident bacteria that are resistant to Paneth-cell secretions stimulate these host-defense mechanisms to prevent competition by nonresident bacteria. The host in turn benefits by decreasing its exposure to potential pathogens," says Tomas Ganz of the University of California, Los Angeles in a commentary accompanying the March report.

Hooper agrees that the normal inhabitants of the gut may use Paneth cells and Ang4 to raise what she calls an "electric fence" to keep out competing microbes. Beyond fending off foreign pathogens, such fences may also keep typical intestinal microbes within the gut. "Anything can become a pathogen if it crosses the fence," she says.

Eating leftovers

Scientists have estimated that the hundreds of bacterial species within the human gut may together possess as many unique genes as a person does, and perhaps far more. "How much of our biology is dependent on metabolic traits encoded in the collective genomes of our microbial partners?" asks Gordon.

Investigators have begun to address that question. For example, Schell recently worked with scientists at the Nestlé Research Center in Lausanne, Switzerland, to unravel some of the genetic secrets of B. longum. This microbe typically colonizes the intestines of a newborn mammal, thrives during the breast-feeding period, and then subsides after weaning, when B. thetaiotaomicron and other bacteria take hold. Nestlé incorporates B. longum into some of its products, such as infant formulas and yogurts, to promote gastrointestinal health.

In the Oct. 29, 2002 Proceedings of the National Academy of Sciences, Schell and his colleagues unveiled the entire DNA sequence of B. longum and identified a large roster of genes for enzymes that break apart sugars and other edible substances. Some of these enzymes may degrade complex sugars found in breast milk, speculates Schell. Others, such as ones that apparently break down plant gums, may help the bacterium survive later in its host's life when B. longum is in the minority in the intestines.

The bacterium appears to break down substances that B. thetaiotaomicron and other Bacteriodes can't handle. "It seems to be more specialized for the leftovers of metabolism," says Schell. In a strategy similar to Gordon's, investigators at Nestlé are now using germfree mice to evaluate B. longum's impact on intestinal genes.

Gordon's team is drawing its own insights from the group's recent deciphering of B. thetaiotaomicron's genome. Among that microbe's nearly 4,800 genes, several hundred encode proteins that bind carbohydrates, enzymes that degrade bonds between sugars, or enzymes that create new sugars, the investigators reported in the March 28 Science. And the activity of many of these genes appears to be regulated by genes encoding molecules related to known environmental sensors, suggesting that the microbe can monitor the contents of the intestines and quickly deploy the molecular machinery needed for it to digest nutrients.

"This organism has a sweet tooth. It knows how to process carbohydrates," says Gordon.

Over the next 5 to 10 years, predicts Schell, researchers will decode the genomes of many more intestinal microbes. Investigators may also begin to address such issues as whether a person's diet changes his or her intestinal microflora. "I think the gut population of a vegetarian is clearly going to be different" from that of a meat eater, says Schell.

Gordon offers an even more provocative question: Do intestinal microbes influence a person's weight? "Over time, could relatively minor differences in the ability to extract nutrients in some individuals predispose them to obesity?" he asks.

The complicated nation of bacteria within our intestines is a "window into our biology and how we've evolved as a species," concludes Gordon.

Cathartic colon is the anatomic and physiologic change in the colon that occurs with chronic use of stimulant laxatives (> 3 times per week for at least 1 year). Signs and symptoms of cathartic colon include bloating, a feeling of fullness, abdominal pain, and incomplete fecal evacuation. Radiologic studies show an atonic and redundant colon. Chronic use of stimulant laxatives can lead to serious medical consequences such as fluid and electrolyte imbalance, steatorrhea, protein-losing gastroenteropathy, osteomalacia, and vitamin and mineral deficiencies. When the drug is discontinued, radiographic and functional changes in the colon may only partially return to normal because of drug-induced neuromuscular damage to the colon.

Anthranoid laxatives (aloe, cascara sagrada, and senna) are derived from naturally occurring plants and are considered to be stimulant laxatives. Short-term use of stimulant laxatives may be safe, but abuse of these drugs can cause melanosis coli and possibly increases the risk of colonic cancer. Melanosis coli, a benign condition, is characterized by dark pigmentation of the colonic mucosa that usually develops 9 months after initiating the use of these drugs and disappears just as quickly after the drug is discontinued.

Aloe, a popular houseplant, has a long history as a multipurpose folk remedy. Commonly known as Aloe vera, the plant can be separated into two basic products: gel and latex. Aloe vera gel is the leaf pulp or mucilage, a thin clear jelly-like substance obtained from the parenchymal tissue that makes up the inner portion of the leaves [1]. The gel contains carbohydrate polymers, such as glucomannans or pectic acid, plus various other organic and inorganic compounds. Aloe latex, commonly referred to as "aloe juice," is a bitter yellow exudate from the pericyclic tubules just beneath the outer skin of the leaves. For pharmaceutical use as a laxative, the juice is often dried to produce "aloe" granules that are dark brown from exposure to air. The terms "gel" and "juice" are not clearly defined by manufacturers and often are confused by consumers.

The mechanical separation process is not always complete, so aloe latex can be found in some aloe gels. It is desirable to make the gel as pure as possible, because aloe latex contains the anthraquinone glycosides aloin A and B, which are potent laxatives [2]. The processed products are difficult to keep stable, a problem that can cause differences in product potency. Many products advertise special stabilizing procedures, but the best source of aloe gel would be direct from a broken leaf of the plant.

Aloe gel has been used for topical treatment of wounds, minor burns, and skin irritations. American consumers are most familiar with aloe's use in skin-care products, but aloe can also be used as a beverage. Aloe products for internal use have been promoted for constipation, coughs, wounds, ulcers, diabetes, cancer, headaches, arthritis, immune-system deficiencies, and many other conditions. However, the only substantiated internal use is as a laxative [3-6]. The anthroquinones and anthrones in the aloe latex probably produce their laxative effect by increasing colonic peristalsis and increasing the intestinal water content by opening chloride channels of the colonic membrane to cause a net reduction of liquid absorption by the colon [4]. The anthroquinone glycosides reach the colon mostly undigested, although some are metabolized by enzymes produced by intestinal bacteria. The result includes more frequent stools with softer consistency. In most of the studies on the laxative effects of aloe, the aloe was not used alone but in combination with other laxatives, such as celandin or psyllium. Aloe's side effects can include abdominal pain, diarrhea, and electrolyte imbalances, especially at higher doses.

Few studies have tested whether taking aloe gel internally can influence wound-healing. One study has demonstrated improved wound healing in mice, which the authors attributed to increased capillary blood flow to the injured areas [7]. During the 1970s, two FDA advisory panels concluded that there was insufficient evidence that aloe vera gel was useful for treating minor burns, cuts, or abrasions, or for treating minor vaginal irritations [8].

One study of 5,000 subjects found a positive effect of lowering risk factors in patients with heart disease. The study showed that by adding Isabgol (which increases the bulk of feces) and aloe vera gel to the diet, there was a marked reduction in total lipids, total serum cholesterol, serum triglycerides, fasting and post-meal blood sugar levels in diabetics, and an increase in HDL [9]. Our January 1998 MEDLINE search found no other studies on blood lipids, heart disease risk, and aloe. Some research has shown decreasing fasting blood sugar in diabetic animals given aloe [10-13]. Further studies are needed to explore these issues in humans.

False advertising claims for aloe are common, especially on the Internet. Some Web pages are making bold claims and using testimonials promoting it for treating the AIDS virus, arthritis, or other chronic and debilitating conditions [14,15]. These claims have not been substantiated by scientific studies.

The safety of aloe is another concern. Genotoxicity studies show that aloe-containing laxatives pose cancer risk to humans when used as directed [4]. Aloe extract can be taken orally as a dietary supplement, but does not have FDA approval for use as a drug [16]. Currently, aloe is a Category I over-the-counter stimulant laxative, meaning that it is generally recognized as safe and effective if used appropriately for this purpose [17]. The FDA recommends further testing and safety data for aloe. Some deaths have been reported of cancer patients who were treated with aloe vera intravenously by a physician whose license was subsequently revoked [16,18-20]. Injection of aloe vera is illegal in the United States, but desperate people can go to other countries where there is less regulation for unproven treatments.

And the supplements seem to offer the most protection against the advanced polyps most strongly associated with invasive colorectal cancer, according to a new study.

"In an earlier publication, we showed a reduction in polyps [with calcium intake]," said Dr. John A. Baron, a professor of medicine at Dartmouth Medical School, and senior author of the study that appears in the June 16 issue of the Journal of the National Cancer Institute.

"There was less than a 20 percent reduction, overall," he added. "Now, we find when we look at more advanced [polyps], it is a much more marked reduction, suggesting that calcium might have a more pronounced effect in preventing advanced [polyps]."

An estimated 106,370 new cases of colon cancer and 40,570 cases of rectal cancer will be diagnosed this year in the United States, according to the American Cancer Society, and about 56,730 deaths will result.

Most colon and rectal cancers begin as a polyp, a growth of tissue into the center of the colon or rectum. Removing polyps, also known as adenomas, early may prevent them from becoming cancerous, according to the Cancer Society.

In new the study, Baron's team analyzed data from 913 patients enrolled in the Calcium Polyp Prevention Study. Patients took either a 1,200 milligram supplement of calcium or a placebo, and had a follow-up colonoscopy -- an exam of the colon -- one and four years after they began the calcium therapy.

Compared with those on a placebo, people taking calcium supplements had fewer of all types of polyps. But the protective effect was most pronounced for the kind of advanced lesions that are most strongly associated with colon cancer. The risk for advanced polyps was reduced by about 35 percent, Baron said.

While it's not known exactly how the calcium may help prevent the polyps, researchers speculate that calcium prevents the irritating and cancer-promoting effect of bile acids and other fats in the bowel.

In an accompanying editorial in the journal, Ulrike Peters, now an assistant faculty member at the Fred Hutchinson Cancer Research Center in Seattle, but formerly a research fellow at the National Cancer Institute, writes that the beneficial effects of calcium supplements still have not been proven. But the protective role of calcium against colon cancer "looks very promising," she said.

For now, she added, those wanting to reduce their risk of colon cancer should follow the dietary recommendation for calcium -- 1,200 milligrams a day for those over 50 years of age, and 1,000 milligrams for those 19 to 50.

"We cannot really tell if there is a difference right now between [calcium from] supplementation and from food," she said. "That needs further investigation.

Dr. Arthur Schatzkin, lead author of the editorial and chief of the nutritional epidemiology branch of the NCI, agreed. "For a variety of health reasons people should try to make sure they are getting adequate intakes of calcium." Calcium helps with bone strength, for one thing. But he cautioned that "...we haven't proved that calcium prevents colon cancer."

Added Baron: "As always, talk to your doctor. It is really thought that calcium supplements are safe, but don't think you can take something like this and forget everything else. Remember, this is just one aspect of what might be done."

He advised people to get colorectal cancer screening tests, such as colonoscopies and occult blood testing. "Exercise is probably beneficial," he added, in helping to reduce colorectal cancer risk.

More information

To learn more about colorectal cancer, visit the National Cancer Institute.

The bacterial microbiota in the human large intestine is thought to compromise 95% of the total cells in the body, representing 1012 cells/g dry weight contents. Through the activities of the resident microflora, the colon plays a major role in host nutrition and welfare (Gibson and Roberfroid 1999). Dietary modulation of the human gut flora can be of great benefit to health. In recent years, the functional food concept has moved away from mineral and vitamin supplementation towards the situation where improved gut (microbial) functionality is the main current driving force. The colon is the most intensely populated region of the gastrointestinal tract (Figure 1) and is therefore the main target for such dietary intervention.

The gastrointestinal tract is a sterile environment at birth and bacterial colonisation begins during the delivery process (organisms are transferred to the newborn gut from the maternal faecal or vaginal flora and/or the environment). Initial bacteria to colonise the colon are facultatively anaerobic organisms, such as Escherichia coli and streptococci. These first colonisers metabolise any traces of oxygen in the gut, thereby reducing the environment into one of strong anaerobic conditions. The bacteria that then further colonise the gut depend largely upon the feeding profile of the infant. The breast fed infant has bifidobacteria as the numerically predominant genus, whereas formula feeds give rise to a more complex, adult-like, gut flora with clostridia, bacteroides, bifidobacteria and streptococci as prevalent genera (Salminen et al. 1998). A major reason for these differences is that breast milk contains a ‘bifidus’ factor, which stimulates growth of bifidobacteria; this is a glycoprotein containing glucose, galactose, fructose, and N-acetyl glucosamine. Breast fed infants generally have less gastrointestinal problems than their formula-fed counterparts and this may well be attributed to the powerful anti-pathogen effects exerted by bifidobacteria. The final phase of microflora acquisition occurs at weaning, when a complex microflora develops. Currently, there is much interest in modulating the constituents of infant formulae, such that bifidobacteria are much more effectively stimulated.

The resident gut microbiota ferments substances, mainly provided by the diet, that cannot be digested by the host in the small gut. These include, resistant starch, non-starch polysaccharides (dietary fibre), oligosaccharides, proteins, amino acids, etc. In a typical adult, around 80 g of food ingested each day reaches the large intestine and is therefore susceptible to fermentation by the gut flora. The two main types of fermentation that are carried out in the gut are saccharolytic and proteolytic. The main end products of carbohydrate metabolism are, the short chain fatty acids, acetate, propionate, and butyrate. These may be further metabolised systemically or locally to provide energy generation for the host. The end products of proteolytic fermentation include, phenolic compounds, amines, and ammonia, all of which are toxic. The proximal colon (right side) is essentially a site of saccharolytic fermentation, whereas the more distal (left side) sees more proteolytic fermentation. This is probably a major reason why many gastrointestinal disorders (including colon cancer, ulcerative colitis) predominate distally.

Dietary modulation of the human gut flora has been carried out for many years. In humans, there are positive aspects to the gut fermentation, which may improve certain aspects of host health. The microflora contains certain bacteria that can be perceived as health promoting, as well as pathogenic. For instance, bifidobacteria and lactobacilli may help to improve resistance to gut infections by inhibiting the growth of harmful microorganisms (that may onset both acute and chronic gut disorder), reduce blood lipid levels, improve the immune response, and be involved in protection against gut cancers (Gibson and Roberfroid 1999; Sanders 1998). The definitive health outcomes, and their mechanisms of effect, are being gradually uncovered and there is currently much interest in increasing numbers and activities of these bacteria in the large gut, preferably at the expense of more harmful species. The manner in which this can be achieved is through dietary supplementation.

The use of probiotics has been widely supported. In this case, foodstuffs such as fermented milk products containing viable cultures perceived as beneficial (e.g. lactobacilli, bifidobacteria) are used to proliferate populations in the colon. Probiotics are defined as live microbial feed supplements, which beneficially affect the host animal by improving its intestinal microbial balance (Fuller 1989). To be effective, probiotics must be capable of being prepared in a viable manner and on large scale (e.g. for industrial purposes), whilst during use and under storage the probiotic should remain viable and stable, be able to survive in the intestinal ecosystem, and the host animal should gain beneficially from harbouring the probiotic. Clearly, the organisms used should be generally regarded as safe.

Whilst records indicate that probiotics have been ingested by humans for thousands of years, the work of Metchnikoff in the Pasteur Institute at the start of the 20th Century was probably the first realistic look at their use. He observed that Bulgarian peasants who consumed fermented dairy products exhibited longevity (Metchnikoff, 1907). In his thesis ‘The Prolongation of Life’ he attributed this to their elevated intake of so called soured milks – what we now recognise as probiotics.

An alternative approach has been investigated where the commensal bifidobacteria and/or lactobacilli are selectively promoted by the intake of certain non-viable substrates, known as prebiotics. Gibson and Roberfroid (1995) first described a prebiotic as a “non-digestible food ingredient that beneficially affects the host by selectively stimulating the growth and/or activity of one or a limited number of bacteria in the colon, and thus improves host health.” As diet is the main factor controlling the intestinal microflora, it is possible to modulate the microflora composition through foods. A prebiotic substrate is selectively utilised by beneficial components of the indigenous gut flora but does not promote growth of potential pathogens, such as toxin producing clostridia, proteolytic bacteroides, and toxigenic Escherichia coli. In this manner, a “healthier” microflora composition is obtained, whereby the bifidobacteria and/or lactobacilli become predominant in the intestine and exert possible health-promoting effects (similar to the situation that prevails in the breast fed infant gut). For a dietary substrate to be classed as a prebiotic, three criteria are required:

1) the substrate must not be hydrolysed or absorbed in the stomach or small intestine;

2) it must be selective for beneficial commensal bacteria in the colon, such as the bifidobacteria;

3) the substrate should induce beneficial luminal/systemic effects within the host.

The premise behind prebiotics is therefore to stimulate certain indigenous bacteria in the gut, rather than introducing exogenous species, as is the case with probiotics. Ingesting a diet containing non-digestible carbohydrates that are selectively fermented by indigenous beneficial bacteria, is the prebiotic principal. Any dietary component that reaches the colon intact is a potential prebiotic, however much of the interest in the development of prebiotics is aimed at non-digestible oligosaccharides, such as fructooligosaccharides (FOS), trans-galactooligosaccharides (TOS), isomaltooligosaccharides (IMO), xylooligosaccharides (XOS), soyoligosaccharides (SOS), glucooligosaccharides (GOS), and lactosucrose. In Europe, FOS, GOS and lactulose have been shown to be prebiotics, through numerous volunteer trials, as evidence by their ability to change the gut flora composition after a short feeding period (Gibson et al. 2000). The Japanese market is more widespread.

As prebiotics exploit the use non-viable dietary components to improve gut health, the range of foods into which they can be added is much wider than that for probiotics, where culture viability needs to be maintained. This has the advantage that heat stability, or exposure to oxygen is not an issue. As such, virtually any carbohydrate containing food is susceptible to supplementation. Examples are shown in Table 1.

On the contrary, it may be possible to intake prebiotics more naturally through the diet. Many fruit and vegetables contain prebiotic oligosaccharides, such as FOS. Examples are onion, garlic, banana, asparagus, leek, and Jerusalem artichoke. However, the likely situation is that levels are too low to have any significant effect. Our (unpublished) data indicate that at least 4g/d, but more preferably 8g/d of FOS, would be needed to significantly elevate bifidobacteria in the human gut. Hence, there exists much value in the approach of dietary fortification. However, it is important to ensure that the prebiotic effect is maintained in the food product. Figure 2 shows data from a recent volunteer trial carried out at the University of Reading (Tuohy et al. 2001). Here, shortbread containing 7g/d FOS was fed to human subjects and the effects upon faecal bacteria determined as compared to a placebo (FOS not added). The nature of the trial was a crossover approach in that volunteers took active and placebo shortbread, but neither they nor the investigators were aware of which was ingested. Moreover, the bacteriology was carried out using a (culture independent) probing approach that relied upon differences in 16SrRNA profiles for the confirmation of identity. The data clearly show that the use of FOS exerted a profound effect upon bifidobacteria.

It is the case that many new products are being, and have been, developed that exploit the prebiotic approach. As mentioned, their use is more widespread than for probiotics. Hence, it is likely that the eventual market value will outstrip that of the live microbial approach (currently estimated at over 1 billion euro p.a. in Europe). There is therefore a huge potential for the use of functional foods, and in particular prebiotics in the food industry. However, it is important that new product developments have satisfactory scientific evidence to back their claims. One difficulty in the past has been the limitations imposed by cultural microbiology when applied to a complex ecosystem, such as the human gut.

Gut microbiology is conventionally carried out by plating faecal microorganisms onto selective agars designed to recover numerically predominant groups. However, the agars used are only semi-selective, do not recover non-culturable bacteria (which may represent over 50% of the overall diversity), and allow operator subjectivity in terms of microbial characterisation, which is usually based on limited phenotypic procedures. As such, alternative mechanisms, based around molecular principles, to more effectively characterise the microflora involved in fermentation studies, need to be applied. The use of such methods gives a much clearer picture of the gut microbiota and the effects of prebiotics. Traditional methods of bacterial enumeration are therefore being replaced with these molecular techniques (Tannock 1999; Vaughan et al. 2000). One such method is fluorescent in situ hybridisation (FISH) using specific rRNA probes, as employed in the study mentioned above (see Figure 3). The application of post-genomic principles in gut microbial studies will help fully explore human gut microflora diversity, develop reliable model systems, test a new generation of purpose designed prebiotic molecules with enhanced functionality, and determine the effectiveness of dietary intervention in the clinical situation.

In terms of new developments, it is important that the definitive health bonuses associated with prebiotic intake be determined. This is especially relevant given the broad applicability of their use. It is likely that prevention of acute gastroenteritis through fortification of certain gut microbiota components is an important aspect. Moreover, improved protection from more chronic gut disorders that have been associated with bacteria (inflammatory bowel disease, colon cancer, irritable bowel syndrome) may also be possible. It may also be the case that certain target populations, such as infants, the elderly, hospitalised persons, are more susceptible to the approach. Finally, the use of synbiotics, where both probiotics and prebiotics are combined, may offer the dual benefits of both approaches, whilst the use of a selective substrate may help long term persistence of the live microorganisms.

Glenn Gibson is Professor of Food Microbiology and Head of Food Microbial Sciences Unit at The University of Reading. Prior to this he was with the Institute of Food Research, Reading and MRC Dunn Laboratories, Cambridge. The Research Unit runs numerous projects on gut microbiology and food safety. Specific interests include, the bacteriology of acute and chronic gut disorders (e.g. gastroenteritis, ulcerative colitis, bowel cancer) and the use of molecular approaches to facilitate characteisation/enumeration of microorganisms. The group are extensively researching prebiotics and probiotics as dietary microflora management tools - in gut model systems and through human studies.

02/02/2004 - Probiotics, the bacteria thought to help gut health disorders, allergies and even some forms of cancer, contain immune system-stimulating DNA, which makes them just as effective when inactivated as when consumed as live microorganisms in dairy products, say US researchers.

The findings, reported in this month’s Gastroenterology (DOI:10.1053/j.gastro.2003.11.019), offer considerable potential for food makers previously restricted to adding bacteria to fermented foods like yoghurt. The study, by researchers at the University of California, San Diego School of Medicine and the Shaare Zedek Medical Center in Jerusalem, Israel, also reveals a mechanism that can be used to determine and to select which probiotic bacteria are best for patients with IBD.

The addition of probiotic bacteria has until now been limited to dairy products such as yoghurt because it was thought that they needed to be live to have any effect. Adding live bacteria to other foods would result in fermentation, changing the taste, texture and freshness on an hourly basis.

But the new research suggests that the metabolic activity of probiotics is not in fact key to their protective effect.

The researchers used gamma radiation to reduce the metabolic activity of probiotic bacteria to a minimum. Previous studies, using heat to inactivate the bacteria, destroyed the cellular structure and beneficial aspects.

The irradiated probiotics were given to mice with experimentally induced colitis, which is similar to human IBD. The irradiated probiotics effectively improved the colitis symptoms, as did the administration of viable, ‘live’ bacteria to another group of mice with colitis. This indicated that inactivated probiotics were as effective as live probiotics.

The scientists say that the beneficial, anti-inflammatory activities seen with the inactivated probiotics could be the product of the innate immune system, the body’s instant response to invasion by pathogens.

The European probiotics market is forecast to more than triple in value from €34.6 million currently to €118.5 million in 2010, according to recent statistics from Frost & Sullivan. But the market research firm also estimated that its gut health cousin, prebiotics, would be helped by much wider scope in applications, as prebiotic ingredients are easily formulated into a number of different foods, including baked goods and even drinks.

The new research could however open a vast range of new application areas to probiotics too. Gut health is currently driving sales of functional foods in Europe, according to a Datamonitor report, outpacing those foods targeting consumers at risk of heart or bone diseases.

In addition to studying the normal and irradiated probiotics on mice, the researchers also tested a synthetic form of bacterial DNA called immunostimulatory (ISS) oligonucleotide (ODN), a short segment of synthetic DNA with immunostimulatory properties, which mimics bacterial DNA. In a previously published paper in Gastroenterology, ISS-ODN had been found to reduce the harmful effects of experimental colitis in mice, indicating that it worked in a manner similar to probiotics.

Evaluation of the immunostimulatory activities of probiotics may also provide an easy screening system for the selection of probiotic bacteria prior to their clinical use, noted the study’s first author, Daniel Rachmilewitz, from the Shaare Zedek Medical Center.

NEW YORK (Reuters Health) Sept 22 - Treatment with the probiotic Lactobacillus paracasei reduces the muscle hypercontractility seen in an animal model of postinfective gut dysfunction, suggesting a possible benefit for patients with postinfective irritable bowel syndrome (IBS), new research shows.

The findings, which appear in the September issue of Gastroenterology, are based on a study of mice that developed gut dysfunction after being infection with Trichinella spiralis. The animals were then treated with various active or heat-inactivated probiotics.

Treatment with L. paracasei several days after infection attenuated the muscle hypercontractility normally seen, lead author Dr. Elena F. Verdu, from McMaster University in Hamilton, Canada, and colleagues note. In contrast, other probiotics, such as L. johnsonii, Bifidobacterium lactis, and B. longum, had no effect.

Further analysis revealed that L. paracasei's effect was associated with a drop in the T. spiralis-related T-helper 2 response and with a reduction in muscle levels of TGF-beta1, cyclooxygenase-2, and prostaglandin E2.

"To our knowledge, no studies have been performed on the effect of probiotics in patients with postinfective IBS," the authors state. "Our results raise the possibility that L. paracasei could be useful in attenuating postinfective gut dysfunction in humans and in treating postinfective IBS."

Researchers from the Mayo Clinic and Mayo Foundation in Rochester, Minnesota, United States, found that the action was unrelated to alteration in gastrointestinal (GI) or colonic transit in a randomised, controlled trial with 25 diarrhoea-predominant IBS patients.

Following a 2-week run-in period, participants were randomly assigned to either VSL#3 or placebo twice daily for eight weeks. Patients underwent pre- and post-treatment measurement of GI transit. They also recorded bowel function and symptoms daily during the 10-week study.

No significant differences were observed between treatment groups pre- or post-therapy on measurements of GI transit, bowel function or satisfactory global symptoms.

The investigators say that further analysis indicated abdominal bloating was reduced in patients receiving VSL#3. This effect was not seen in patients receiving placebo.

"With the exception of changes in abdominal bloating, VSL#3 had no effect on other individual symptoms: abdominal pain, gas and urgency," they report.

All patients were able to tolerate the probiotic.
Alimentary Pharmacology 2003;17:7:895-904. "A randomized controlled trial of a probiotic, VSL#3, on gut transit and symptoms in diarrhoea-predominant irritable bowel syndrome"

Single-blind follow-up study on the effectiveness of a symbiotic preparation in irritable bowel syndrome

J TSUCHIYAR BARRETOR OKURAS KAWAKITAE FESCEF MAROTTA

Abstract

OBJECTIVE:

Experimental and clinical studies have shown that a novel symbiotic (known as SCM-III) exerts a beneficial effect on gut translocation and local and systemic inflammatory and microbial metabolic parameters. The present investigation was a preliminary trial on the effectiveness of SCM-III for irritable bowel syndrome (IBS).

METHODS:

Sixty-eight consecutive adult patients with IBS who were free from lactose malabsorption, abdominal surgery, overt psychiatric disorders and ongoing psychotropic drug therapy or ethanol abuse were studied prospectively and divided into 2 groups that were comparable for age, gender, body size, education and pattern of presenting symptoms. The 2 groups were blindly given for 12 weeks either SCM-III 10 mL t.i.d or the same dosage of heat-inactivated symbiotic.

RESULTS:

Treatment with SCM-III was ‘effective’ or ‘very effective’ in more than 80% of the patients (P < 0.01 vs baseline values and control). Less than 5% reported ‘not effective’ as the final evaluation compared with over 40% of patients in the control group. After 6 weeks of treatment, a significant improvement of pain and bloating was reported in the treatment group compared with control and baseline values. There was also a benefit for bowel habits, mostly for patients with constipation or alternating bowel habits. No overt clinical or biochemical adverse side-effects were recorded.

CONCLUSION:

Compared with baseline values and the control group, SCM-III resulted in a significant increase in lactobacilla, eubacteria and bifidobacteria, which suggests that some selected IBS patients could benefit substantially from symbiotics, but the treatment may need to be given on a cyclic schedule because of the temporary modification of the fecal flora.

05/01/2005 - The popular herbal tea camomile may help relieve a wide range of health ailments, finds new research.

The study lends some scientific support to use of the tea as an ancient remedy for numerous conditions.
Elaine Holmes, a chemist at Imperial College London, recruited 14 volunteers (seven women and seven men) who each drank five cups of the herbal tea daily for two consecutive weeks. The tea was made with the flowers and leaves of German camomile (Matricaria recutita), also known as manzanilla.

Daily urine samples were taken and tested throughout the study, both before and after drinking camomile tea.

The researchers found that drinking the tea was associated with a significant increase in urinary levels of hippurate, a breakdown product of certain plant-based compounds known as phenolics, some of which have been associated with increased antibacterial activity.

This could help explain why the tea appears to boost the immune system and fight infections associated with colds, say the researchers in the 26 January issue of the Journal of Agricultural and Food Chemistry.

Drinking the tea also was associated with an increase in urinary levels of glycine, an amino acid that has been shown to relieve muscle spasms. This could be responsible for its benefit in relieving menstrual cramps in women, probably by relaxing the uterus, noted the researchers.

Glycine also is known to act as a nerve relaxant, which may explain the mildly sedative effect of the tea.

Levels of both hippurate and glycine remained elevated for up to two weeks after the study participants stopped drinking the tea, indicating that the compounds may remain active for quite some time.

Additional studies are needed before a more definitive link between the tea and its alleged health benefits can be established.

Holmes commented: “This is one of a growing number of studies that provide evidence that commonly used natural products really do contain chemicals that may be of medicinal value.”

Funding for the study was provided by UK-based Oxford Natural Products.

The online version of study was initially published on the journal's website on 21 December.

Abstract: Goals: To assess the incidence of oral complementary and alternative medicine (CAM) usage by gastroenterology patients at a single university center and compare against controls.

Background: The public awareness and usage of CAM have increased. The use of CAM has been described in patients with functional bowel disorders; however, their role in patients with gastrointestinal disease is less clear.

Study: Patients attending luminal gastroenterology clinics and customers at local supermarkets completed a 30-point, structured questionnaire assessing their use of CAM.

Results: A total of 1,409 subjects were recruited. The incidence of CAM use was 49.5% for inflammatory bowel disease, 50.9% for irritable bowel syndrome, 20% for general gastrointestinal diseases, and 27% for controls. Pearson's [chi]2 tests showed that patients with inflammatory bowel disease (IBD) or irritable bowel syndrome were more likely to use CAM than controls (P < 0.001). Binary logistic regression analysis showed that females were more likely to take CAM than men (P < 0.05).

Conclusions: The percentage of CAM users among patients with IBD is similar to those with a functional diagnosis. Increasing numbers of IBD patients are using CAM in addition to conventional therapy. Awareness of this may prevent adverse CAM and conventional drug interactions.

31/03/2005 - A drink containing a probiotic strain isolated from infants relieved symptoms of irritable bowel syndrome to the same extent as pharmaceutical treatments for the condition, report Irish researchers.

The team from the Alimentary Pharmabiotic Centre, set up last year at Ireland’s University College Cork to investigate bacteria and gut health, found that patients who consumed a malted milk drink containing Bifidobacterium infantis 35624 everyday for eight weeks experienced fewer overall symptoms, abdominal pain and discomfort.
The symptom relief was comparable to that seen with Zelnorm (tegaserod) and Lotronex (alosetron), drugs that have been recently approved for the treatment of irritable bowel syndrome (IBS).

IBS is a long-term condition that usually involves cramping, diarrhoea and constipation. It affects between 10 and 15 per cent of the Irish population and a similar proportion of people in other western countries.

However the precise cause of IBS is not fully understood and there is no cure yet. Treatments are aimed at alleviating symptoms but medication, for those with moderate to severe forms of the disease, does not work for all patients.

Senior author on the new study, Professor Eamon Quigley, who is head of UCC’s medical school, said the results "look very good in comparison to pharmacological products".

"We believe we have very significant results. It is at least as effective as lots of available products, and probiotics have a good safety profile too," he told NutraIngredients.com.

In contrast, treatment with another probiotic bacteria, Lactobacillus salivarius UCC4331, also isolated at the Irish centre, appeared to have no more effect on IBS symptoms than a placebo drink.

Both strains, patented by UCC, had shown interesting properties in laboratory studies.

“Previous studies of probiotic preparations have been small and used different probiotics, different doses and different definitions of IBS. Ours is one of the first properly powered trials conducted to accepted standards in this area,” Dr Quigley added.

For the study, published in the March issue of Gastroenterology (vol 128, issue 3, pp541-51), 77 people with IBS were asked to drink a malted milk drink every morning. The drink either contained L. salivarius, B. infantis or no added bacteria. The subjects recorded their symptoms.

“Our hypothesis is that low-grade inflammation is a factor in IBS and that certain probiotic bacteria can reduce this inflammation. We have some evidence to support this theory because our paper shows a change in cytokine ratios after the probiotic treatment," said Dr Quigley.

He added that further clinical trials are ongoing and research into the mechanism will also be carried out by the team.

Neither of the strains is currently commercially available but the APC works in partnership with Procter and Gamble and is hoping to bring the bacteria to market in new products.

By Greg Arnold, DC, CSCS, May 3, 2005, abstracted from “Fiber supplements may lower cardiovascular risk in type 2 diabetics” from an American Heart Association press release April 30, 2005.

For the 16 million Americans with Type 2 Diabetes, health complications are numerous and costly, making up much of the $132 billion spent each year to treat type 2 diabetes.1 From the threat of kidney failure to blindness to nerve damage and foot infections and skin problems,2 type 2 diabetes takes a heavy toll on your health.

Now, a new study3 has found that a relatively simple supplement can help prevent heart disease in type 2 diabetics, perhaps the worst health consequence of the condition.

In the study, researchers had 78 participants with type 2 diabetes take 10g to 15g of an over-the-counter fiber supplement in 5-gram doses two to three times daily 5 to 10 minutes before eating. Total blood cholesterol, triglycerides, LDL (“bad” cholesterol) and HDL (“good” cholesterol) were measured at the beginning of the study and at 90 days.

At the end of 90 days, researchers found “remarkable” results. In addition to observing both total cholesterol and triglyceride levels drop more than 14 percent, LDL levels decreased nearly 29 percent and HDL levels increased 21.8 percent. All of these results have been found to help decrease the risk for heart disease.

What’s more, all the subjects taking the fiber were virtually free of side effects.

But perhaps the most important statement of all made by the researchers was the potential for fiber supplementation to be a viable alternative to statin drugs, the most popular class of cholesterol-lowering drugs.

For the researchers, “the study demonstrates that dietary fiber supplements may be an alternative to statins for people with moderately high cholesterol who are unable or unwilling to take statins.”

The firm’s RaftiloseSynergy1, an enriched inulin powder, increased calcium retention and accretion in bones by 15 per cent after a year, reported the firm today. The findings will be a major boost to the ingredient as food makers seek to offer products to consumers that are increasingly aware of the threat of osteoporosis.

The bone-wasting disease now affects an estimated 75 million people in Europe, USA and Japan, according to the International Osteoporosis Foundation.

Many young girls get as little as 10 per cent of the calcium they need each day, often a result of avoiding dairy products. But by increasing the mineral density of bone in early life and retaining it, osteoporosis risk can be significantly reduced.

Previous studies have shown that taking 8g of Orafti's oligofructose-enriched inulin increased the calcium absorbed from the diet by up to 20 per cent.

The new study, carried out by Professor S.Abrams from the Baylor College of Medicine and the Texas Children's Hospital in Houston, shows a significant 15 per cent increase of calcium retention and accretion within the bones of the 100 girls and boys, aged nine to 13, after one year of supplementation.

Dr Anne Franck, vice president of science and technology at Orafti, said: "If effects are not long-term they have little clinical benefit. The Abrams research is physiologically significant as it provides an insight into the longer-term effect of RaftiloseSynergy1 and demonstrates that it can be highly beneficial in increasing bone mineral density."

She added that standard inulin and oligofructose also improve mineral absorption, but only at higher dosages, so they are not suitable for related health claims.

"With the patented RaftiloseSynergy1, calcium absorption and bone density claims are possible with only 8g/day," said Dr Franck.

For the study, half of the sample was provided with 8g of RaftiloseSynergy1 to consume with breakfast each day for a year, while the other half was provided with a placebo. Prior to the start of the research, all participants underwent measurements of calcium absorption and retention, via blood and urine samples, and bone mineral content and density, via X-ray body scans. These tests were repeated after two months and at the end of the year-long study.

Regular checks were also made on the participants' average daily diet in order to ensure that no significant changes in calcium intake occurred. Calcium intake was maintained throughout the study at usual levels around 900 mg/day.

Dr Franck said: "Absorption of an adequate amount of calcium is particularly important during early adolescence in order to achieve an optimal peak bone mass. In doing this, and by further ensuring that the maximum amount of calcium is retained in the bones throughout adulthood, the chances of developing conditions such as osteoporosis later in life can be reduced."

The short oligofructose fraction in RaftiloseSynergy1 can thoroughly change the flora in the proximal part of the colon, and the more slowly fermented inulin can function as a selective 'fuel' for this modified flora, which is kept metabolically active further in the gut. This selective fermentation pattern results in the production of short chain fatty acids. These acids decrease the pH within the colon, improving the solubility of the calcium present, which is then better absorbed into the body.

Commensal bacteria inhabiting the human intestine (i.e., intestinal microflora) participate in the development and maintenance of gut sensory and motor functions, including the promotion of intestinal propulsive activity. On the other hand, intestinal motility represents one of the major control systems of gut microflora, through the sweeping of excessive bacteria from the lumen. There is emerging evidence indicating that changes in this bidirectional interplay contribute to the pathogenesis of gut diseases, such as small intestinal bacterial overgrowth and intestinal pseudo-obstruction. Recent interest has also been directed to the potential role of intestinal microflora in the pathogenesis of the irritable bowel syndrome. Although the status of intestinal microflora in the irritable bowel syndrome remains unsettled, small intestinal bacterial overgrowth (as detected with breath testing) and increased fermentation of foods with gas production, provide indirect evidence that microflora may contribute to symptom generation in irritable bowel syndrome. The potential benefit of antibiotic and probiotic therapy is currently under investigation and opens new perspectives in irritable bowel syndrome treatment.

Methods: A total of 103 patients fulfilling the Rome I or II criteria took part in this 6-month, randomized, double-blind placebo-controlled trial. The patients received a probiotic capsule or a placebo capsule daily. Gastrointestinal symptoms and bowel habits were recorded.

Results: At the end the total symptom score (abdominal pain + distension + flatulence + borborygmi) was 7.7 (95% CI: 13.9 to 1.6) points lower in the probiotic group (P = 0.015). This represents a median reduction of 42% in the symptom score of the probiotic group compared with 6% in the placebo group. In individual symptoms, borborygmi was milder in the probiotic group (P = 0.008), and for the rest of the symptoms there was a non-significant trend.

Conclusions: The results indicate that this probiotic mixture is effective in alleviating irritable bowel syndrome symptoms. Considering the high prevalence of irritable bowel syndrome and the lack of effective therapies, even a slight reduction in symptoms could have positive public health consequences.

Oct. 14, 2005 — Melatonin may reduce the pain associated with irritable bowel syndrome (IBS), according to the results of a small, double-blind study reported in the October issue of Gut.

“Melatonin, a sleep promoting agent, is involved in the regulation of gastrointestinal [GI] motility and sensation,” write G. H. Song, MD, from the National University of Singapore, and colleagues. “In view of the high prevalence of sleep disturbance in IBS patients, and the possible double effects of melatonin in regulating sleep pattern and bowel function, we hypothesised that melatonin may be useful in the treatment of IBS, and its therapeutic effects might be most evident if it was used in IBS patients who suffer from concomitant sleep disturbance.”

In this study, 40 patients with IBS and sleep disturbances were randomized to receive either melatonin (3 mg) or matching placebo at bedtime for two weeks. There were 24 women and 16 men; age range was 20 to 64 years. Assessments immediately before and after treatment included patient-completed bowel, sleep, and psychological questionnaires; rectal manometry; and overnight polysomnography (PSG).

“Administration of melatonin 3 mg at bedtime for two weeks significantly attenuated abdominal pain and reduced rectal pain sensitivity without improvements in sleep disturbance or psychological distress,” the authors write. “The findings suggest that the beneficial effects of melatonin on abdominal pain in IBS patients with sleep disturbances are independent of its action on sleep disturbances or psychological profiles.”

Study limitations include small sample size, short treatment period, use of only one dose of melatonin, and limited sensitivity of the hospital anxiety and depression scale.

“Future studies should focus on therapy with different doses of melatonin, prolonging the treatment period, and using a larger sample size to provide a clearer view of the role of melatonin in IBS and sleep disturbance,” the authors conclude.

The authors have disclosed no financial relationships.

Gut. 2005;54:1402-1407

Learning Objectives for This Educational ActivityUpon completion of this activity, participants will be able to: Describe the effect of two weeks of melatonin on abdominal pain and rectal pain sensitivity in IBS. Describe the effect of two weeks of melatonin on sleep disturbances in IBS. Clinical ContextSleep disturbance is commonly observed in patients with IBS, occurring in 26% to 55%. Also, patients with IBS have more REM sleep characterized by arousal, according to the current authors. Melatonin is a close derivative of serotonin and is involved in the sleep-wake cycle via the pineal gland. The GI tract is another source of melatonin, which may exert excitatory and inhibitory effects regulating bowel motility. Melatonin may act by improving gut visceral hypersensitivity. The current authors postulated the melatonin supplementation may relieve bowel and sleep disturbances in patients with IBS with an effect on overall symptoms. This is a double-blind, randomized, placebo-controlled trial to examine the efficacy of 3 mg of melatonin once daily on IBS symptoms and sleep disturbances.

Study HighlightsInclusion criteria were age 20 to 64 years with IBS diagnosis made by an experienced gastroenterologist using Rome II criteria and sleep disturbance, defined as difficulty getting to sleep, awakening at night, and early morning wakening. Patients had a Pittsburgh sleep quality index (PSQI) score greater than 5 and sleep disturbance at least two nights a week for 12 weeks. Exclusion criteria were pregnant or breast-feeding, organic GI, hepatic, or other systemic disorders, history of GI surgery, or cerebral disease. At baseline an IBS symptom scale, hospital anxiety and depression scale, PSQI and Epsworth Sleepiness scale (ESS) were administered to assess bowel, sleep, and psychological functioning. Patients also underwent rectal manometry to measure squeeze, push, and resting pressures; and overnight PSG at home, which included electroencephalogram, electrooculogram, nasal airflow pressure, electromyogram, and electrocardiogram. These measures were repeated at the end of the study. 20 patients were randomized to receive 3 mg of melatonin orally at bedtime and 20 patients to identical-appearing placebo. Mean age was 27 years, one third was men, and two thirds had the constipation or diarrhea subtype of IBS. All patients completed the study. None reported adverse effects. Abdominal pain score was significantly reduced in the melatonin vs the placebo group (2.35 vs 0.70; P < .001) after 2 weeks of treatment. There was greater reduction in abdominal distension, stool frequency, and total bowel symptoms in the melatonin group. There were no significant differences in stool type, abnormal sensation of defecation, or quality of life between the two groups. Rectal distension pressures required to induce feelings of urgency and pain were significantly increased in the melatonin (from 18.4 - 23.0 mm Hg and from 24.8 - 33.7 mm Hg, respectively) vs the placebo group. Distension pressure thresholds for the first sensation of distension or desire to defecate did not change or differ between the 2 groups. There were no differences in rectal pressures during resting, pushing, or voluntary squeezing conditions between the 2 groups. Sleep parameters including global PSQI score, sleep quality, latency, duration, efficiency, disturbance, use of sleep medications, and daytime dysfunction were not significantly different between the 2 groups. ESS scores were similar between the 2 groups. PSG findings for REM sleep, onset latency, arousal index, and amount of REM vs non-REM sleep were similar between the 2 groups. Pearls for PracticeUse of 3 mg of melatonin once daily for two weeks in IBS patients is associated with improvement in bowel pain and rectal distension thresholds for urgency and pain but not with a change in stool frequency, type, or quality of life. Melatonin at 3 mg daily for two weeks is not associated with improvement in sleep disturbance.

He explained that lab animals with ulcerative colitis, and in humans with IBS, treatment with B. infantis 35624 reverses severe inflammation of the colon "and restores the immune balance from a pro-inflammatory state to an anti-inflammatory state."

To determine the impact of the probiotic on bowel movement frequency, Dr. Quigley, from University Cork College in Ireland, and colleagues randomly assigned 85 female patients with IBS to treatment with B. infantis 35624 for 4 weeks and 80 to treatment with an inert placebo.

For patients with very frequent or very few bowel movements, the bacteria had a significant effect in normalizing the frequency, the investigators reported this week at the annual meeting of the American College of Gastroenterology in Honolulu.

This is "a unique finding," Quigley noted, since "the other agents used or tested in IBS have tended to have efficacy in either a diarrhea-predominant group or a constipation-predominant group, but not in both."

Changes in bowel frequency were accompanied by "very significant improvement in individual symptoms, such as pain and bloating," he added.

"If we continue to show true efficacy for probiotics," the researcher maintained, "this will represent a major step forward because they have the great advantage of having no safety issues to confront."

Ginger (rhizome of Zingiber officinale) has been widely used for centuries in gastrointestinal disorders, particularly dyspepsia, but its precise mode of action has yet to be elucidated.

This study was undertaken to study the prokinetic action of ginger and its possible mechanism of action. Prokinetic activity of ginger extract (Zo.Cr) was confirmed in an in vivo test when it enhanced the intestinal travel of charcoal meal in mice. This propulsive effect of the extract, similar to that of carbachol, was blocked in atropine-pretreated mice, a standard cholinergic antagonist. Likewise, Zo.Cr showed an atropine-sensitive dose-dependent spasmogenic effect in vitro as well as in isolated rat and mouse stomach fundus tissues.

In atropinized tissue, it showed spasmolytic activity as shown by the inhibition of 5-HT- and K+-induced contractions. A spasmolytic effect was also observed in other gut preparations either as noncompetitive inhibition of agonist dose–response curves, inhibition of high K+(80 mM)-induced contractions, or displacement of Ca2+ dose–response curves to the right, indicating a calcium antagonist effect.

Phytochemical analysis revealed the presence of saponins, flavonoids, and alkaloids in the crude extract. These data indicate that Zo.Cr contains a cholinergic, spasmogenic component evident in stomach fundus preparations which provides a sound mechanistic insight for the prokinetic action of ginger.

In addition, the presence of a spasmolytic constituent(s) of the calcium antagonist type may explain its use in hyperactive states of gut like colic and diarrhea.
Keywords: Zingiber officinale; ginger; prokinetic; cholinergic; calcium antagonist

Given the absence of a cure and the adverse effects of medications, patients with IBS often turn to complementary therapies. Peppermint possesses antispasmodic properties and has long been associated with improvement of digestive function. Peppermint leaves contain oils that have mild anesthetic properties, relieve nausea, and relax smooth muscle spasticity caused by histamine and cholinergic stimulation. A systematic review identified five trials that showed that peppermint oil relieved IBS symptoms. Three of these trials showed statistically significant benefit of peppermint over placebo (P < .001). The placebo response ranged from 13 to 52 percent with a mean of 31 percent including all five trials. A randomized double-blind placebo-controlled study28 of enteric-coated peppermint oil involving 110 patients showed 79 percent with less pain, 83 percent with decreased stool frequency, and 79 percent with less flatulence. Peppermint is contraindicated in patients with gastroesophageal reflux disease.

Background: Traditional herbal therapies have been used for a long time to treat gastrointestinal disorders including irritable bowel syndrome, and their effectiveness from clinical research evidence needs to be systematically reviewed.

Objectives: To assess the effectiveness and safety of herbal medicines in patients with irritable bowel syndrome.

Search strategy: We searched the following electronic databases till July 2004: The Cochrane Library (CENTRAL), MEDLINE, EMBASE, AMED, LILACS, the Chinese Biomedical Database, combined with hand searches of Chinese journals and conference proceedings till end of 2003. No language restriction was used.

Data collection and analysis: Data were extracted independently by two authors. The methodological quality of trials was evaluated using the components of randomisation, allocation concealment, double blinding, and inclusion of randomised participants.

Authors' conclusions: Some herbal medicines may improve the symptoms of irritable bowel syndrome. However, positive findings from less rigorous trials should be interpreted with caution due to inadequate methodology, small sample sizes, and lack of confirming data. Some herbal medicines deserve further examination in high-quality trials.

In a literature search 16 clinical trials investigating 180-200 mg enteric-coated peppermint oil (PO) in irritable bowel syndrome (IBS) or recurrent abdominal pain in children (1 study) with 651 patients enrolled were identified. Nine out of 16 studies were randomized double blind cross over trials with (n = 5) or without (n = 4) run in and/or wash out periods, five had a randomized double blind parallel group design and two were open labeled studies.

Placebo served in 12 and anticholinergics in three studies as comparator. Eight out of 12 placebo controlled studies show statistically significant effects in favor of PO. Average response rates in terms of "overall success" are 58% (range 39-79%) for PO and 29% (range 10-52%) for placebo. The three studies versus smooth muscle relaxants did not show differences between treatments hinting for equivalence of treatments. Adverse events reported were generally mild and transient, but very specific. PO caused the typical GI effects like heartburn and anal/perianal burning or discomfort sensations, whereas the anticholinergics caused dry mouth and blurred vision. Anticholinergics and 5HT3/4-ant/agonists do not offer superior improvement rates, placebo responses cover the range as in PO trials.

Taking into account the currently available drug treatments for IBS PO (1-2 capsules t.i.d. over 24 weeks) may be the drug of first choice in IBS patients with non-serious constipation or diarrhea to alleviate general symptoms and to improve quality of life.

In today's climate, changed lifestyles and the increased use of antibiotics are significant factors that affect the preservation of a healthy intestinal microflora. The concept of probiotics is to restore and maintain a microflora advantageous to the human body. Probiotics are found in a number of fermented dairy products, infant formula, and dietary supplements. Basic research on probiotics has suggested several modes of action beneficial for the human body and clinical research has proven its preventive and curative features in different intestinal and extraintestinal diseases. Chronic diseases cause considerable disablement in patients and represent a substantial economic burden on healthcare resources. Research has demonstrated a crucial role of nutrition in the prevention of chronic disease. Thus, positive, strain-specific effects of probiotics have been shown in diarrheal diseases, inflammatory bowel diseases, irritable bowel syndrome, and Helicobacter pylori-induced gastritis, and in atopic diseases and in the prevention of cancer. As the majority of probiotics naturally inhabit the human intestinal microflora, their use has been regarded as very safe. However, in view of the range of potential benefits on health that might be achieved by the use of some probiotic bacteria, major and thorough evaluation is still necessary. In conclusion, probiotics act as an adjuvant in the prevention and treatment of a wide variety of chronic diseases.

SettingColorectal surgical practice and community in Minneapolis, Minnesota, USA.

Participants42 adults (mean age 61 y) with at least weekly faecal incontinence of loose or liquid stools. Exclusion criteria were rectal prolapse, colon cancer, rectal fistula, ulcerative colitis, or removal of some portion of the gastrointestinal tract. No participant had biofeedback training for pelvic muscle exercises. Follow up was 93%.

InterventionParticipants were allocated to receive 31 days of dietary fibre supplementation with psyllium 7.1 g/day (n=13); gum arabic 25 g/day (n=13); or placebo given as pectin 0.25 g/day (n=13). Supplements were mixed into fruit juice and divided into 2 servings for consumption during the morning and evening meals. Participants were instructed to maintain their usual diet. Those who were taking antidiarrhoeal medication were advised not to alter the type and amount during the study.

Main resultsThe rates of incontinent stools for the psyllium and gum arabic groups were lower than for the placebo group (table). The psyllium and gum arabic groups had lower rates of loose and unformed or liquid stools than did those in the placebo group (2(6)=20.8, p=0.002). No difference existed between the 3 groups for stool frequency, wet weight of stool, or weight of total stool solids.

View this table:[in this window][in a new window] Psyllium, gum arabic, and placebo for faecal incontinence at 8 days

ConclusionIn adults living in the community, dietary fibre supplementation with psyllium or gum arabic reduced the rate of incontinent stools and improved stool consistency.

FootnotesSources of funding: National Institute of Nursing Research; National Institutes of Health; American Federation for Aging Research; Sigma Theta Tau Zeta Chapter; University of Minnesota

By Neil Osterweil, Senior Associate Editor, MedPage Today
Reviewed by Robert Jasmer, MD; Assistant Professor of Medicine, University of California, San Francisco
April 25, 2006
Also covered by: BBC News

MedPage Today Action Points

Explain to interested patients that this study suggests that probiotics may help to protect the gut against stress-induced intestinal disease.

Caution patients that this study was conducted only in animal models.

Review
TORONTO, April 24 — Probiotics can help protect the gut against harmful bacteria and symptoms brought on by long-term stress, according to researchers here.

In a study of rats subjected to stress, those who were pretreated with either of two Lactobacillus strains had less adhesion to intestinal walls of harmful bacteria, said Philip M. Sherman, M.D., and colleagues at the Hospital for Sick Children here.

What's more, pretreatment with the probiotics prevented translocation of the harmful bacteria to the mesenteric lymph nodes, indicating a protective effect, they reported in the early online issue of Gut.

Although the study focused on stressed-out rodents, the findings have implications for the treatment of inflammatory bowel disease and irritable bowel syndrome in humans, the authors wrote.

"Enhanced bacterial uptake following exposure to chronic stress may lead to an increased antigen load in the intestinal mucosa," Dr. Sherman and colleagues wrote. "Thus local inflammation could be initiated, which eventually leads to more diffuse intestinal inflammation… In addition, these findings indicate that probiotics may provide a novel approach for the management of stress induced intestinal dysfunction."

Dr. Sherman and colleagues looked at the ability of probiotics to prevent intestinal pathophysiology precipitated by stress. In this case, the stress was induced by a water avoidance stress test, in which the animals were placed for one hour per day for 10 days on a small platform surrounded by warm water in a plastic container. Controls were subjected to "sham stress," in which they were placed on an identical platform in an empty plastic container.

The animals had been fed either a standard diet or the same diet with probiotics (Lactobacillis helveticus and L. rhamnosus strains) added to the water for seven days before the start of the induced stress and continuing for the duration of the study.

"We have previously shown that probiotics survive and transiently colonize the gut when administered to mice via addition to sterile drinking water," the authors noted.

Four hours after the last real or sham stress session, the rats were killed and their tissues, including mesenteric lymph nodes and intestinal segments, were examined for studies of bacterial translocation, and morphological and functional analysis.

The authors found that the chronic stress caused by water-avoidance induced excess ion secretion and intestinal mucosal barrier dysfunction in both the ileum and the colon, and that these effects were associated with increased bacterial adhesion and penetration into surface epithelial cells.

They also saw that about 70% of the rats subjected to the water avoidance stress had bacterial penetration of the gut endothelium and translocation of the bacteria to mesenteric lymph nodes.

However, pretreatment with probiotics reduced the number of adherent bacteria, prevented bacterial translocation to mesenteric lymph nodes, and inhibited chronic stress-induced elevated intestinal ion secretion, but not increased permeability, the authors found.

The pathogenesis of constipation remains to be completely defined, although the condition is commonly categorized as normal-transit constipation, pelvic floor dysfunction, and slow-transit constipation. The role of bacteria in the generation of constipation symptoms has begun to receive considerable attention, and one report has shown an association between excess methane production and slow colonic transit. In an interesting study involving 22 patients with slow-transit constipation documented by radio-opaque markers, Schlieger and colleagues randomized subjects to receive either Lactobacillus casei (6.5 x 109 colony forming units/day) or placebo for 4 weeks. Measurement of colonic transit time was repeated after 4 weeks. Patients in the Lactobacillus group had an objective improvement in colonic transit time from 95.6 hours to 77 hours (P < .05), primarily due to more rapid transit through the rectosigmoid colon. Patients in the placebo group noted a slight reduction in transit time as well (from 93.7 hours to 87.1 hours), although this was not statistically significant.

The study authors did not report symptom response and did not report whether colonic transit time worsened after Lactobacillus treatment had stopped. Future studies are needed to verify this finding and determine the relationship between probiotic use and colonic transit.

Peppermint (Mentha piperita L.) is one of the most widely consumed single ingredient herbal teas, or tisanes. Peppermint tea, brewed from the plant leaves, and the essential oil of peppermint are used in traditional medicines. Evidence-based research regarding the bioactivity of this herb is reviewed. The phenolic constituents of the leaves include rosmarinic acid and several flavonoids, primarily eriocitrin, luteolin and hesperidin. The main volatile components of the essential oil are menthol and menthone. In vitro, peppermint has significant antimicrobial and antiviral activities, strong antioxidant and antitumor actions, and some antiallergenic potential. Animal model studies demonstrate a relaxation effect on gastrointestinal (GI) tissue, analgesic and anesthetic effects in the central and peripheral nervous system, immunomodulating actions and chemopreventive potential. Human studies on the GI, respiratory tract and analgesic effects of peppermint oil and its constituents have been reported. Several clinical trials examining the effects of peppermint oil on irritable bowel syndrome (IBS) symptoms have been conducted. Adverse reactions to peppermint tea have not been reported, although caution has been urged for peppermint oil therapy in patients with GI reflux, hiatal hernia or kidney stones. Copyright (c) 2006 John Wiley & Sons, Ltd.

The data on these agents originally suffered from poor study design, limits on generalizability and commercial bias: true 'junk science'. Reviews mentioning them still grossly outnumber studies with primary data, but the application of better study design supports their use. Thus far, there are more data for probiotic use in ulcerative colitis than in Crohn's disease. VSL#3 is a combination of probiotic strains that has been shown to maintain remission and decrease the incidence of pouchitis. Recent open-label data suggest that it may have utility for the induction of remission in patients with ulcerative colitis.[24] In this small study of 34 patients with moderately active ulcerative colitis, there was a 77% response rate, indicating that the VSL#3 probiotic mixture induces remission in patients with active ulcerative colitis. A German study[25] found equivalent efficacy of Escherichia coli Nissle 1917 and mesalazine in maintaining remission in ulcerative colitis. Although interesting, these must be considered grade III data and require more extensive exploration and validation in large-scale clinical trials.

BackgroundAntibiotic-associated diarrhea (AAD) and Clostridium difficile disease (CDD) are common conditions linked to the use of antibiotics. Studies evaluating the efficacy of probiotics for the treatment of these two conditions have produced contradictory results.

ObjectivesTo determine the efficacy and safety of probiotics for the prevention of AAD and CDD.

Design and InterventionThe databases of PubMed, MEDLINE, Google Scholar, metaRegister, the NIH registry of clinical trials, and the Cochrane Central Register of Controlled Trials were searched to identify studies suitable for inclusion in the meta-analysis. In addition, reference lists, commentaries, books, and meeting abstracts were examined. Keywords, including "probiotics", "Clostridium difficile", "antibiotics", "diarrhea", "Saccharomyces", and "Lactobacilli" were used to carry out the search. Studies were eligible for inclusion if they were published between 1977 and 2005 in peer-reviewed publications, used human subjects, and were randomized controlled trials (RCTs) that examined efficacy. Exclusion criteria included case reports, Phase I safety studies, and trials that used unspecified probiotics. Diarrhea was defined as loose stools within 24 h for 2 days, or loose stools within 48 h. AAD was defined as diarrhea within 2 months of exposure to antibiotics. CDD was defined as diarrhea associated with a positive Clostridium difficile culture or toxin within a month of exposure to antibiotics. The quality of suitable studies was assessed according to a number of factors, including study design, sample size, and outcome measures. A quality grade was given to each study: 1 = poor, 2 = fair, 3 = good.

Outcome MeasureThe main outcome measure was identification of studies suitable for inclusion in the meta-analysis.

ResultsIn total, 31 RCTs were included in the meta-analysis, and all were rated fair or good quality. Of these, 25 featured patients with AAD, and collectively contained the data of 2,810 patients, and 6 featured patients with CDD, and collectively contained data on 354 patients. Meta-analysis revealed that probiotics had a significant protective effect for the development of AAD (relative risk [RR] 0.43, 95% CI 0.31-0.58, P <0.001). In a further meta-analysis by probiotic strain, Saccharomyces boulardii (S. boulardii), Lactobacillus rhamnosus GG (L. rhamnosus GG), and a mixture of two strains of Lactobacilli showed significant efficacy for treating AAD (RR 0.34, 95% CI 0.26-0.52; P <0.0001; RR 0.31, 95% CI 0.13-0.72; P = 0.006; and RR 0.51, 95% CI 0.38-0.68; P <0.0001, respectively). Meta-analysis also revealed that probiotics had a significant protective effect for the development of CDD (RR =0.59, 95% CI 0.41-0.85; P = 0.005). S.boulardii was the only probiotic that showed a significant reduction in the recurrence of CDD. Overall, 24 trials reported no adverse events, and those that did reported minor adverse events, including thirst and constipation.

ConclusionS. boulardii, L. rhamnosus GG, and probiotic mixtures significantly reduced the development of AAD. S. boulardii significantly reduced the development of CDD.

CommentaryProbiotics feature in a number of commercially successful products and dietary supplements, which are widely available in pharmacies, drugstores, and even supermarkets. Many people consider probiotics to be natural, beneficial agents that can exert favorable effects on health. The intestinal tract is the main target of the action of probiotics, and probiotics are perceived to be especially effective in treating diarrhea. Scientists, however, are more cautious about this claim, mainly because of the plethora of probiotic-containing products that are available. In addition, some products do not even seem to contain what they claim.[1]

AAD is an important indication for probiotics, which can re-establish the unbalanced composition of intestinal microflora, enhance immune response, and clear pathogens from the host. Published studies in this setting vary greatly in terms of trial design, type and dose of probiotic, and duration of treatment and therefore sometimes yield contradictory and inconclusive results. The lack of definitive evidence about the efficacy and the safety of probiotics has hampered their acceptance and use as a treatment for AAD and CDD. Previous meta-analyses[2,3] have examined only a limited number of trials, and failed to emphasize possible publication bias or data heterogeneity.

In this article, McFarland reports an exhaustive meta-analysis of 31 carefully selected, good-quality trials involving 2,810 patients with AAD, and 354 patients with CDD, who were treated with probiotics. Two single probiotic strains—S. boulardii and L. rhamnosus GG—as well as mixtures of different types of Lactobacilli, showed significant efficacy in AAD. Only S. boulardii, however, proved to be effective in preventing recurrences of CDD.

The first take-home message from this paper is that probiotics do exert the therapeutic effects on AAD in clinical practice that were anticipated from a theoretical point of view. This is extremely important because clinicians now have scientific evidence of a therapeutic indication that had, so far, remained controversial. The second, equally important message is that, once again, probiotics are an extremely heterogeneous group of micro-organisms that are endowed with different properties and modes of action. The assumption that the therapeutic effects of a particular probiotic agent might be attributed to other similar strains, or to the whole probiotic family, is totally wrong. Each agent must be tested and evaluated separately; admittedly, this is a time-consuming process, but it is the only way to obtain scientific evidence. Similarly, the efficacy of a probiotic in a specific disorder (e.g. AAD) does not automatically mean that the particular product will also be beneficial in other intestinal conditions (e.g. IBD or IBS), and vice versa. Finally, physicians must bear in mind that probiotics do not consist of only or mainly Lactobacilli. One of the few probiotic agents that have been proved to be effective in AAD, and the only one able to prevent CDD recurrence, is S. boulardii. This probiotic is a nonpathogenic yeast that, incidentally, has shown promising preliminary results as a supportive measure in the treatment of IBD.[4,5]

Practice point

Probiotics are effective for treating antibiotic-associated diarrhea and Clostridum difficile disease; Lactobacillus rhamnosus GG is effective for antibiotic-associated diarrhea, Saccharomyces boulardii is effective for both

The synopsis was written by Rachel Jones, Associate Editor, Nature Clinical Practice.

Comparison of the effectiveness of fennel and the non-steroidal anti-inflammatory drug mefenamic acid on pain intensity in dysmenorrhoea.

Modaress Nejad V, Asadipour M.

Department of Obstetrics and Gynaecology, Kerman University of Medial Sciences and Health Services, Kerman, Islamic Republic of Iran.

A study in Kerman, Islamic Republic of Iran in 2002 compared the effectiveness of fennel and mefenamic acid on pain relief in primary dysmenorrhoea. Two groups of high-school girls (mean age 13 years) suffering dysmenorrhoea were randomized to receive fennel extract (n = 55) or mefenamic acid (n = 55) for 2 months. In the fennel group, 80% of girls and in the mefenamic acid group, 73% of girls showed complete pain relief or pain decrease, while 80% in the fennel group and 62% in the mefenamic acid group no longer needed to rest. There was no significant difference between the 2 groups in the level of pain relief.

BACKGROUND: Probiotic bacteria exhibit a variety of properties, including immunomodulatory activity, which are unique to a particular strain. Thus, not all species will necessarily have the same therapeutic potential in a particular condition. We have preliminary evidence that Bifidobacterium infantis 35624 may have utility in irritable bowel syndrome (IBS). OBJECTIVES: This study was designed to confirm the efficacy of the probiotic bacteria B. infantis 35624 in a large-scale, multicenter, clinical trial of women with IBS. A second objective of the study was to determine the optimal dosage of probiotic for administration in an encapsulated formulation. METHODS: After a 2-wk baseline, 362 primary care IBS patients, with any bowel habit subtype, were randomized to either placebo or freeze-dried, encapsulated B. infantis at a dose of 1 x 10(6), 1 x 10(8), or 1 x 10(10), cfu/mL for 4 wk. IBS symptoms were monitored daily and scored on to a 6-point Likert scale with the primary outcome variable being abdominal pain or discomfort. A composite symptom score, the subject's global assessment of IBS symptom relief, and measures of quality of life (using the IBS-QOL instrument) were also recorded. RESULTS: B. infantis 35624 at a dose of 1 x 10(8) cfu was significantly superior to placebo and all other bifidobacterium doses for the primary efficacy variable of abdominal pain as well as the composite score and scores for bloating, bowel dysfunction, incomplete evacuation, straining, and the passage of gas at the end of the 4-wk study. The improvement in global symptom assessment exceeded placebo by more than 20% (p < 0.02). Two other doses of probiotic (1 x 10(6) and 1 x 10(10)) were not significantly different from placebo; of these, the 1 x 10(10) dose was associated with significant formulation problems. No significant adverse events were recorded. CONCLUSIONS: B. infantis 35624 is a probiotic that specifically relieves many of the symptoms of IBS. At a dosage level of 1 x 10(8) cfu, it can be delivered by a capsule making it stable, convenient to administer, and amenable to widespread use. The lack of benefits observed with the other dosage levels of the probiotic highlight the need for clinical data in the final dosage form and dose of probiotic before these products should be used in practice.

INTRODUCTION: The use of peppermint oil in treating the irritable bowel syndrome has been studied with variable results probably due to the presence of patients affected by small intestinal bacterial overgrowth, lactose intolerance or celiac disease that may have symptoms similar to irritable bowel syndrome.

AIM: The aim of the study was to test the effectiveness of enteric-coated peppermint oil in patients with irritable bowel syndrome in whom small intestinal bacterial overgrowth, lactose intolerance and celiac disease were excluded.

METHODS: Fifty-seven patients with irritable bowel syndrome according to the Rome II criteria, with normal lactose and lactulose breath tests and negative antibody screening for celiac disease, were treated with peppermint oil (two enteric-coated capsules twice per day or placebo) for 4 weeks in a double blind study. The symptoms were assessed before therapy (T(0)), after the first 4 weeks of therapy (T(4)) and 4 weeks after the end of therapy (T(8)). The symptoms evaluated were: abdominal bloating, abdominal pain or discomfort, diarrhoea, constipation, feeling of incomplete evacuation, pain at defecation, passage of gas or mucus and urgency at defecation. For each symptom intensity and frequency from 0 to 4 were scored. The total irritable bowel syndrome symptoms score was also calculated as the mean value of the sum of the average of the intensity and frequency scores of each symptom.

RESULTS: At T(4), 75% of the patients in the peppermint oil group showed a >50% reduction of basal (T(0)) total irritable bowel syndrome symptoms score compared with 38% in the placebo group (P<0.009). With peppermint oil at T(4) and at T(8) compared with T(0) a statistically significant reduction of the total irritable bowel syndrome symptoms score was found (T(0): 2.19+/-0.13, T(4): 1.07+/-0.10*, T(8): 1.60+/-0.10*, *P<0.01 compared with T(0), mean+/-S.E.M.), while no change was found with the placebo.

Irritable bowel syndrome (IBS) may, in part at least, result from a dysfunctional interaction between the indigenous flora and the intestinal mucosa which, in turn, leads to immune activation in the colonic mucosa. Some propose a role for bacterial overgrowth as a common causative factor in the pathogenesis of symptoms in IBS; other evidence points to more subtle qualitative changes in the colonic flora; both hypotheses remain to be confirmed but the likelihood that bacterial overgrowth will prove to be a major factor in IBS now seems remote. Nevertheless, short-term therapy with either antibiotics or probiotics does seem to reduce symptoms among IBS patients. It seems most likely that the benefits of antibiotic therapy are mediated through subtle and, perhaps, localized, quantitative and/or qualitative changes in the colonic flora. How probiotics exert their effects remain to be defined but an anti-inflammatory effect seems likely. While this approach to the management of IBS is in its infancy, it is evident that manipulation of the flora, whether through the administration of antibiotics or probiotics, deserves further attention in IBS.

Probiotics, defined as live organisms that, when ingested in adequate amounts, exert a health benefit on the host, have been used for almost a century in the management of a variety of medical disorders, usually on the basis of little evidence. Advances in our understanding of the gut flora and of its relationship to the host, together with progress in microbiology, molecular biology and clinical research have identified important biological properties for probiotics and demonstrated efficacy in a number of gastrointestinal disorders. The clear delineation of a post-infective variety of irritable bowel syndrome (IBS), as well as the description, in a number of studies, of evidence of low-grade inflammation and immune activation in IBS, suggest a role for a dysfunctional relationship between the indigenous flora and the host in IBS and, accordingly, provide a clear rationale for the use of probiotics in this disorder. Other modes of action, including bacterial displacement and alterations in luminal contents, are also plausible. While clinical evidence of efficacy is now beginning to emerge, a review of available trials emphasises the importance of clear definition of strain selection, dose and viability. This is evidently an area of great potential in IBS and deserves further study at all levels.

April 13, 2007 — Peppermint oil is effective in treating digestive disorders and other conditions including headaches, although high dosages may cause adverse effects, according to the results of a review reported in the April 1 issue of American Family Physician.

"The medicinal use of peppermint and other mint plants probably dates back to the herbal pharmacopoeia of ancient Greece, where peppermint leaf traditionally was used internally as a digestive aid and for management of gallbladder disease; it also was used in inhaled form for upper respiratory symptoms and cough," write Benjamin Kligler, MD, MPH, from the Albert Einstein College of Medicine of Yeshiva University in New York, and Sapna Chaudhary, DO, from the Beth Israel Continuum Center for Health and Healing in New York. "Peppermint oil, which is extracted from the stem, leaves, and flowers of the plant, has become popular as a treatment for a variety of conditions, including irritable bowel syndrome (IBS), headache, and non-ulcer dyspepsia."

Specific applications of note are as follows:

Peppermint leaf and oil have a long history of use for digestive disorders.

Peppermint oil has relaxant effects on smooth muscle. When given via enema, it has been shown to be modestly effective in relieving colonic spasm in patients undergoing barium enemas (evidence rating, B).Although peppermint oil is well tolerated at the commonly recommended dosage, it may cause significant adverse effects at higher dosages. Common adverse effects include allergic reactions, heartburn, perianal burning, blurred vision, nausea, and vomiting. Interstitial nephritis and acute renal failure are rare.

Because peppermint oil may inhibit the cytochrome P450 1A2 system, it may interact with drugs metabolized via this system.

Peppermint oil is contraindicated in patients with hiatal hernia, severe gastroesophageal reflux, and gallbladder disorders and should be used with caution in pregnant and lactating women.

The recommended dosage is 0.2 to 0.4 mL of peppermint oil 3 times daily in enteric-coated capsules for adults, and 0.1 to 0.2 mL of peppermint oil 3 times daily for children older than 8 years.

"Peppermint oil should not be used internally or on or near the face in infants and young children because of its potential to cause bronchospasm, tongue spasms, and, possibly, respiratory arrest," the authors conclude. "However, the amount of peppermint in over-the-counter medications, topical preparations, and herbal teas is likely safe in pregnant and lactating women and in young children."

The authors have disclosed no relevant financial relationships.

Am Fam Physician. 2007;75:1027-1030.

Clinical ContextPeppermint has been used as a medicinal substance for thousands of years. Most modern preparations of peppermint use its oil, which usually is provided with an enteric coating to prevent gastroesophageal reflux. This oil contains menthol, menthone, cineol, and other oils, and there is evidence that this combination of compounds can relax gastrointestinal smooth muscle as well as lower esophageal sphincter pressure.

Peppermint oil has been used to treat not only gastrointestinal complaints but also headache. The current article reviews the efficacy and safety of peppermint oil for these indications.

Study HighlightsPeppermint oil appears to be mildly effective in reducing symptoms of IBS, particularly flatulence, abdominal pain, and distension, in adults. However, there has been significant heterogeneity among research into this subject. A study of children between the ages of 8 and 17 years who had IBS found that peppermint oil was more effective than placebo in reducing the severity of abdominal pain. 2 trials have demonstrated that treatment with peppermint oil reduced the risk for gastrointestinal spasm during barium enema, with peppermint associated with up to a 3-fold increase vs placebo in the rate of having a procedure free of spasm. The combination of 90 mg of peppermint oil plus 50 mg of caraway oil has been demonstrated to reduce symptoms of nonulcer dyspepsia, including fullness, bloating, and spasm. This combination should be used cautiously for patients with dyspepsia, as peppermint oil may promote gastroesophageal reflux. 2 studies have delineated the efficacy of topical peppermint oil in tension headache. In 1 study, a combination of peppermint and ethanol was superior to placebo in terms of analgesia. Another trial demonstrated that topical peppermint oil was similar to acetaminophen in terms of treatment efficacy. The therapeutic dosage in most trials of peppermint oil and IBS was 0.2 to 0.4 mL taken 3 times daily in enteric-coated capsules. The 1 trial examining its use for childhood IBS used a dosage of 0.1 mL of peppermint oil 3 times daily for children weighing less than 45 kg. Peppermint oil can be toxic in overdose, leading to interstitial nephritis and acute renal failure. Because it may promote gallstone formation, it should not be used in patients with cholelithiasis or cholecystitis. Peppermint oil also may trigger menstruation and should not be used during pregnancy. The most common adverse events associated with peppermint oil include allergic reactions, heartburn, perianal burning, blurred vision, nausea, and vomiting. Peppermint oil may inhibit the cytochrome P450 1A2 system. Pearls for PracticePeppermint oil contains menthol, menthone, and cineol and may work by relaxing smooth muscle in the gastrointestinal tract. Peppermint oil also may reduce lower esophageal sphincter pressure and therefore usually is supplied with enteric coating. Peppermint oil offers mild efficacy for symptoms of IBS and may improve colonic spasm associated with barium enema. Topical formulations of peppermint oil may improve tension headache.

OBJECTIVE: The aim of this study was to extend a previous 2-week assessment of a probiotic-prebiotic complex in patients with irritable bowel syndrome (IBS).

METHODS: In this open-label, partially controlled, 1-year (14 [2] months) extension study, data were collected from patients with IBS who continued treatment following a 2-week study of the efficacy of the probiotic-prebiotic complex. Data were collected at 2 and approximately 60 weeks after the end of the original study.

RESULTS: A total of 25 patients entered the 2-week extension and 22 completed the approximately 60-week follow-up study (20 women, 2 men; age range, 20-70 years; all white). Results in the control group 2 weeks after crossover to treatment were similar to those from the original study, with reductions in IBS subsyndromes, as follows: general ill feelings/nausea (P < 0.001), indigestion/flatulence (P < 0.001), and marginally colitis (P < 0.03 [1-tailed]). Treatment was associated with a continued reduction in general ill feelings/nausea at 4 weeks (P < 0.007). At >or=52-week follow-up, the rate of remissions was 81.5% to 100% (P < 0.003).

CONCLUSION: Based on the results from the present 1-year extension study, treatment with this probiotic-prebiotic complex may be an option for short-term (2-4 weeks) and long-term ( approximately 60-week) reductions in IBS symptoms.

Irritable bowel syndrome (IBS) may result from a dysfunctional interaction between the indigenous flora and the intestinal mucosa, which in turn leads to immune activation in the colonic mucosa. Some propose that bacterial overgrowth is a common causative factor in the pathogenesis of symptoms in IBS; others point to evidence suggesting that the cause stems from more subtle qualitative changes in the colonic flora.

Bacterial overgrowth will probably prove not to be a major factor in what will eventually be defined as IBS. Nevertheless, short-term therapy with either antibiotics or probiotics seems to reduce symptoms among IBS patients. However, in the long term, safety issues will favor the probiotic approach; results of long-term studies with these agents are eagerly awaited.

The clear delineation of a post-infective variety of IBS, as well as the description, in a number of studies, of evidence of low-grade inflammation and immune activation in IBS, suggest a role for a dysfunctional relationship between the indigenous flora and the host in IBS and, accordingly, provide a clear rationale for the use of probiotics in this disorder.

Other modes of action, including bacterial displacement and alterations in luminal contents, are also plausible. While clinical evidence of efficacy is now beginning to emerge, a review of available trials emphasizes the importance of a clear definition of strain selection, dose and viability. The possible roles of co-therapy or sequential therapy with antibiotics, probiotics, prokinetics, or other agents also deserves further study.

The role of the enteric flora is evidently an area of great potential in IBS; we are on the threshold of a new era of research and therapy for this common disorder.

PURPOSE: This study was designed to evaluate whether probiotics improve symptoms in patients with irritable bowel syndrome.

METHODS: PubMed, Embase, Scopus, Web of Science, and Cochrane Central Register of Controlled Trials were searched for studies that investigated the efficacy of probiotics in the management of irritable bowel syndrome. Clinical improvement was the key outcome of interest. Data were searched within the time period of 1966 through September 2007.

Irritable bowel syndrome (IBS) is a chronic disorder characterized by abdominal pain, change in bowel habit, and bloating. It has traditionally been viewed as a disorder of visceral hypersensitivity heavily influenced by stress, and therefore therapeutic strategies to date have largely reflected this. However, more recently, there is good evidence for a role of the gastrointestinal (GI) microbiota in its pathogenesis. Changes in fecal microbiota, the use of probiotics, the phenomenon of postinfectious IBS, and the recognition of an upregulated host immune system response suggest that an interaction between the host and GI microbiota may be important in the pathogenesis of IBS. This article explores the role of the GI microbiota in IBS and how their modification might lead to therapeutic benefit.

Background: The human gut harbours a complex community of bacteria whose relationship with their host is normally mutually beneficial. Recent studies suggest a disturbance of this relationship in irritable bowel syndrome (IBS) and the potential to correct this using pre- and probiotics. Aims: to review the mechanisms of action of probiotics and prebiotics in IBS and to assess their performance in clinical trials. Methods: Articles relating to modes of action and randomised control trials of treatment were reviewed by searching PubMed using terms "probiotic""prebiotic" and "irritable bowel". Small uncontrolled studies in IBS have been excluded. Results: Probiotics enhance gut barrier function, inhibit pathogen binding and modulate gut inflammatory response. They also reduce visceral hypersensitivity associated with both inflammation and psychological stress. Probiotics can alter colonic fermentation and stabilise the colonic microbiota. Several large randomised, placebo-controlled trials of adequate design have shown an improvement in flatulence and abdominal distension with a reduction in composite IBS symptoms scores. Conclusions: Each probiotic has unique features and IBS patients are heterogeneous. Future efforts should be directed to identifying biomarkers of responsiveness to facilitate better targeting of treatment and hence improved efficacy.

The present study was undertaken to determine the prebiotic efficacy of gum arabic upon consumption by man for up to 4 weeks and, if any, to establish the dose-effect relationship. Human healthy volunteers consumed various daily doses (5, 10, 20, 40 g) of gum arabic (EmulGold(R)) in water for up to 4 weeks.

Daily consumption of water was taken as the negative control and that of 10 g inulin as the positive control. At 0, 1, 2 and 4 weeks quantification of bacterial numbers in stool samples was performed via real time-PCR techniques and questionnaires were filled in to account for potential drawbacks.

The genera of Bifidobacteria and Lactobacilli were taken as potentially beneficial bacteria and those of Bacteroides, Clostridium difficile and Enterococci as potentially non-beneficial, this distinction was dependent on the issue of these numbers being or becoming out of balance in the host. Compared with the negative control the numbers of Bifidobacteria and Lactobacilli 4 weeks after consumption were significantly higher for gum arabic: the optimal dose being around 10 g.

Moreover, at this dose the numbers of Bifidobacteria, Lactobacilli and Bacteroides were significantly higher for gum arabic than for inulin. No significant drawback was encountered during the study. It is concluded that gum arabic establishes prebiotic efficacy, at least as good as inulin. The optimal daily dose was found to be 10 g.

New Study Shows Health Benefits of Probiotic Could Extend Beyond Gastrointestinal System

Data from a recent study demonstrate the anti-inflammatory and pathogen protection benefits of Bifidobacterium infantis 35624 a probiotic bacterial strain of human origin. Gastrointestinal benefits of probiotics have been well-documented, but more and more research is revealing that probiotic benefits extend to the entire body. The report was published in the August issue of the Public Library of Science (PLoS) Pathogens.

Newswise — Data from a recent study demonstrate the anti-inflammatory and pathogen protection benefits of Bifidobacterium infantis 35624 a probiotic bacterial strain of human origin. Gastrointestinal benefits of probiotics have been well-documented, but more and more research is revealing that probiotic benefits extend to the entire body. The report was published in the August issue of the Public Library of Science (PLoS) Pathogens .

The inflammatory response is a key part of the immune system’s battle against invaders. The normal response to infection is rapid and effective, however, the immune response may occasionally cause inflammation and damage to healthy tissue.

“Inflammation is a major factor in a number of chronic diseases affecting millions of people and can cause an unwanted impact on healthy tissue,” said Dr. Liam O’Mahony, lead investigator. “Past research has shown that the probiotic Bifidobacterium infantis 35624 can positively impact the body’s immune defense3, and this most recent data suggests that its benefits are not restricted to the gastrointestinal tract.”

Inflammation is associated with a wide range of conditions, such as inflammatory bowel disease, arthritis, bacterial-induced colitis, type I diabetes and organ transplantation. Bifidobacterium infantis 35624 has previously shown ability to modulate the inflammatory response in a clinical trial of patients with irritable bowel syndrome.2 The new data suggests additional health benefits of this particular probiotic strain.

The published study examined the effect of Bifidobacterium infantis 35624 administration on immunity to Salmonella (Salmonella typhimurium), harmful bacteria that can cause intestinal infections and trigger the body’s inflammatory response. Bifidobacterium infantis 35624, a probiotic strain isolated from healthy human gastrointestinal tissue, was administered to mice in freeze-dried powder at least three weeks prior to salmonella infection. Animals that received Bifidobacterium infantis 35624 showed dramatically increased numbers of certain immune cells that control the immune system response to harmful pathogens, in this case Salmonella.

Additionally, data show increased numbers of T-regulatory (Treg) cells, or cells that suppress inflammatory disease in a wide range of autoimmune diseases. Administration of Bifidobacterium infantis 35624 resulted in the induction of these Treg cells, which protected the host from excessive inflammation during the course of infection. Researchers concluded that the introduction of Bifidobacterium infantis 35624 results in enhanced protection from infection, while limiting pro-inflammatory damage caused by superfluous activation of the innate immune system.

About Alimentary Health

Alimentary Health is a development stage specialty biotechnology company located in Ireland. The company is focused on the discovery, development and commercialization of proprietary probiotic and pharmabiotic treatments for gastrointestinal disorders and other inflammatory conditions. Alimentary Health is the foundation industry partner of the Alimentary Pharmabiotic Center based at University College Cork, Ireland. www.alimentaryhealth.ie

THURSDAY, Nov. 13 (HealthDay News) -- For some patients, the best therapy for irritable bowel syndrome (IBS) may be older, cheaper drugs such as fiber, antispasmodics and peppermint oil, a new study finds.

According to researchers, these simple treatments have fallen out of favor because of the availability of newer (and more expensive) drugs, some of which have been taken off the market due to safety concerns.

But more traditional therapies should become first-line treatments in guidelines for the treatment of IBS, the experts say.

"IBS can be difficult for physicians to treat," noted lead researcher Dr. Alex Ford, from McMaster University, Health Sciences Centre in Ontario, Canada.

"New drugs are always being developed, but recent ones such as alosetron and tegaserod have been withdrawn, and are now only available on a restricted basis, and renzapride has not been shown to be effective," he said. On the other hand "older drugs, which are cheap, safe, and in some cases available over the counter, appear to be effective in IBS."

The report is published in the Nov. 14 online edition of the BMJ.

As many as 45 million Americans may have IBS, the International Foundation for Functional Gastrointestinal Disorders reports. Between 60 percent and 65 percent of IBS sufferers are women.

In addition to pain and discomfort, people with IBS experience chronic or recurrent constipation or diarrhea -- or bouts of both. While the exact cause of the condition isn't known, symptoms seem to result from a disturbance in the interaction of the gut, brain and nervous system, according to the foundation.

For the study, Ford's team reviewed trials that compared IBS treatment with fiber antispasmodics and peppermint oil to a placebo or no treatment. The trials included more than 2,500 IBS patients.

The researchers found that fiber, antispasmodics and peppermint oil were effective treatments for IBS. Specifically, that meant that to prevent IBS symptoms in one patient, 11 needed to be treated with fiber, five with antispasmodics, and 2.5 with peppermint oil.

There were no serious side effects associated with any of these treatments, the researchers note.

Peppermint oil appeared to be the most effective therapy of those reviewed, the researchers found.

In trials comparing fiber with placebo, insoluble fiber such as bran was not effective. Instead, only soluble fiber, such as ispaghula husk, reduced symptoms. For antispasmodics, the most effective was hyoscine. This should be used first among antispasmodics, Ford's group advised.

"Physicians, particularly those in primary care, who are being asked to take increasing responsibility for the management of IBS, should consider the use of these agents as first-line therapies for IBS," Ford said.

Dr. Roger Jones, from Kings College London and author of an accompanying journal editorial, welcomed the study.

"These treatments might be slightly more effective than recently thought and they are worth trying," Jones said.

For some patients with pain and diarrhea the antispasmodics may be useful. Patients with constipation should try fiber and for other patients, peppermint oil may be helpful, Jones said.

"If you have IBS which is not under reasonably good control or you are not happy with your symptom profile, you should see your primary-care doc or gastroenterologist for review and perhaps remind them that there is new evidence about the effectiveness of these traditional medicines and you would like to give it a go," Jones said.

"Alternatively, if you feel sufficiently well-informed and confident, you can go do it yourself and get these treatments at the pharmacy," Jones added.

- First Study of its Kind Shows That Consumption of Activia(R) Helps Reduce Abdominal Distension Among People With IBS

Distension of the tummy can be reduced by up to 78% in people with Irritable Bowel Syndrome (IBS) simply by eating probiotic yogurt, according to a UK study published today in Alimentary Pharmacology & Therapeutics (http://www.apandt.org).

The research gives new hope for people with IBS (constipation predominant - IBS-C) who can experience distension of the tummy - the physical increase in waist measurement - by as much as 12cm over the course of a day.(1)

The results showed that daily consumption of yogurt (Activia(R)), containing the probiotic Bifidobacterium lactis DN-173 010, over a four week period, significantly reduced distension as well as improving gastrointestinal transit time, and reduced the overall IBS severity and associated discomfort such as abdominal pain.

The groundbreaking study carried out at the University Hospital of South Manchester, involved 34 adult women - all of whom suffered from IBS-C. Half of the women ate Activia each day, while the other half received a non-fermented dairy (control) product. All patients kept symptom diaries, for regular assessment of abdominal pain, flatulence, bloating and distension.

Commenting on the study, conducted in his Unit at Wythenshawe Hospital, Professor Whorwell said: "Constipation, bloating and distension are common and distressing features of IBS with some sufferers being so bloated by the end of the day that they have to loosen clothing. Distension is associated with delayed gastrointestinal transit and one of the mechanisms by which Activia may be helping this problem is by the acceleration of transit which we confirmed in our study. Now healthcare professionals can advise that taking this probiotic yogurt may alleviate some of the symptoms experienced by IBS sufferers. A simple step to take without any risk of side effects."

Kirsten Hamilton, who has suffered from chronic IBS symptoms, was also impressed by the positive effects she felt after consuming the yogurt. She said: "The pain, discomfort and bloating I suffered as a result of my IBS is now a thing of the past. I truly believe in the benefits of eating Activia every day and continue to do so. I'm no longer filled with dread when I pull my jeans on in the morning!"

Trevor Datson, external communications director at Danone, commented: "This study builds on previous trials that demonstrate the benefit of Activia on the management of IBS symptoms. It adds to the body of evidence that Activia can both help improve digestive comfort and improve gastrointestinal transit time.

He continued: "It is important to remember that the findings of this study are specific to Activia, which contains the unique strain Bifidobacterium lactis DN-173 010, and can't be extrapolated to other probiotic products. Different probiotic products can have very different effects, so you should always look for one that has a scientifically proven effect."

A Systematic Review and Meta-Analysis: Probiotics in the treatment of Irritable Bowel Syndrome.

Hoveyda N, Heneghan C, Mahtani KR, Perera R, Roberts N, Glasziou P.

ABSTRACT: BACKGROUND: Irritable Bowel Syndrome (IBS) is a common chronic gastrointestinal disorder and the evidence for efficacy of most drug therapies in the treatment of IBS is weak. A popular alternative is probiotics, which have been used in several conditions including IBS. Probiotics are live microbial food supplements. The aim of this systematic review and meta-analysis of randomized trials study was to evaluate the efficacy of probiotics in alleviating symptoms in patients with irritable bowel syndrome. We searched Ovid versions of MEDLINE (1950-2007), EMBASE (1980-2007), CINAHL (1982-2007), AMED (1985-2007), the Cochrane library and hand searched retrieved papers.

RESULTS: We identified 14 randomized placebo controlled trials. Combined data suggested a modest improvement in overall symptoms after several weeks of treatment: for dichotomous data from seven trials the overall Odds Ratio (OR) was 1.6 (95% CI, 1.2 to 2.2); for continuous data from six trials the standardised mean difference (SMD) was 0.23 (95% CI, 0.07 to 0.38). For individual symptoms the results differed between the pooled dichotomous and pooled continuous data. Trials varied in relation to the length of treatment (4-26 weeks), dose, organisms and strengths of probiotics used.

CONCLUSION: Probiotics may have a role in alleviating some of the symptoms of IBS, a condition for which currently evidence of efficacy of drug therapies is weak. However, as IBS is a condition that is chronic and usually intermittent longer term trials are recommended. Such research should focus on the type, optimal dose of probiotics and the subgroups of patients who are likely to benefit the most.

A Mayo Clinic research study published in the January issue of the American Journal of Gastroenterology finds that St. John's wort is not an effective treatment for irritable bowel syndrome (IBS). While antidepressants are frequently used to treat IBS, to date, no study has examined the success of using the herbal supplement St. John's wort in treating IBS.

"Our study investigated if herbal antidepressants such as St. John's wort could benefit irritable bowel disease patients," says Yuri Saito, M.D., M.P.H., gastroenterologist and lead physician scientist on the study. "Several of the chemical neurotransmitters that are in the brain are also in the colon. Therefore, it's been thought that antidepressants may affect sensation in the colon in a similar way to how they affect sensation in the brain. Our goal was to evaluate the usefulness of St John's wort in treating IBS."

In this placebo-controlled trial, 70 participants with IBS were randomized where half the patients received St. John's wort and the other half received a placebo for three months. In all, 86 percent of the participants were women, and the median age was 42 years. After three months of observing symptoms such as stomach pain, diarrhea, constipation and bloating, Mayo researchers found that the placebo group had a better response than the group taking the herbal supplement, St. John's wort.

"Because people tend to struggle with IBS for several years, patients are really looking for inexpensive, over-the-counter treatments such as St. John's wort," says Dr. Saito. "Unfortunately, our study showed that St. John's wort was not successful in helping IBS patients."

St. John's wort is an herbal supplement derived from the St. John's wort plant. It has been shown to be helpful in several medical conditions such as depression as well as other pain syndromes. Research has shown it to be as effective as conventional, prescription anti-depressants in treating mild to moderate depression.

"The challenge with IBS is that there is no cure, no one treatment tends to be wholly effective and some treatments come with significant side effects," explains Dr. Saito. "However, well-designed studies of herbal supplements are important so that physicians and patients can make informed decisions about which supplements to recommend or try. Studies of alternative treatments are generally lacking and patients are forced to use a "trial and error" approach to over-the-counter treatments for their IBS."

IBS is a common disorder that affects the colon and commonly causes cramping, abdominal pain, bloating, gas, diarrhea and constipation. Approximately 58 million people struggle with IBS, mostly women.

NEW YORK (Reuters Health) - "Stealth fiber" increasingly added to processed foods, while not a problem for most, can cause gastrointestinal discomfort for some who may not know they're consuming too much of it, Minnesota researchers warn. The fiber is called "inulin."

"Normal fiber foods like wheat bran and legumes are self-limiting, it's hard to over eat them," Joanne Slavin, a registered dietitian in the department of food science and nutrition at the University of Minnesota at St. Paul, told Reuters Health.

Inulin, she explained, may be in chocolate bars, drinks, and snacks around the house, and "before you know it, you may eat more than you can tolerate and have gastrointestinal issues you wouldn't necessarily associate" with those foods.

Inulin is a carbohydrate fiber that occurs naturally in many foods like bananas, wheat, onions and garlic. Found in high concentrations in chicory root, is can be extracted for industrial use. Unlike more familiar carbohydrates, which are broken down in the small intestines and turned into fuel for the body, inulin passes through the small intestines to the colon where it stimulates the growth of "good bacteria" and is fermented by bacteria. In some people it can cause gas, bloating, flatulence, and diarrhea.

Because of its growing popularity as a food additive, Slavin and her colleagues wanted to assess how much inulin it takes to cause gastrointestinal problems.

They designed a study involving 26 healthy men and women aged 18 to 60. After a night of fasting, once a week for five weeks, participants were fed a breakfast of a bagel with cream cheese and orange juice. The orange juice was mixed with a placebo or with 5- or 10-gram doses of two commonly used inulin products -- native inulin and shorter-chain oligofructose.

After their "fiber challenge," participants were called several times over two days and asked about symptoms such as gas/bloating, nausea, flatulence, stomach cramping, diarrhea, constipation and GI rumbling.

Those that got any dose of inulin generally reported "mild symptoms"; the highest scores in every symptom except constipation were reported by those who got 10 grams of oligofructose. The findings are in line with previous research that found the short-chain "sweet" inulin causes faster fermentation in the gut leading to more gas and gastrointestinal symptoms.

Flatulence was the most common symptom reported by all subjects who got fiber although symptoms were "highly variable" among individuals and many subjects did not experience any, the investigators say.

Slavin and colleagues conclude, based on their study, that most healthy people can tolerate up to 10 grams of native inulin and 5 grams of the "sweet" inulin a day.

Food manufacturers, faced with demands to reduce calories, fat, and sodium while increasing fiber and flavor, are increasingly turning to products like inulin. They have discovered they can chemically manipulate the chemical structure of inulin to mimic tastes and textures consumers want in food. "It's like a food manufacturer's nirvana," Slavin said.

Inulin can be found in high fiber breakfast bars, ice creams, and beverages among other processed foods. The label may list inulin, chicory root extract, oligosaccharide, or oligofructose. For example, the Fiber One Chewy Bar with 9 grams of dietary fiber lists chicory root extract as its top ingredient.

Slavin and her colleagues urge continued study of tolerance levels of food additives like inulin because their use is likely to continue to grow and "there is the potential for overuse."

The research was funded by Cargill, Inc. a maker of inulin food additives, which provided the product used in the study.

SOURCE: link.reuters.com/tur56m Journal of the American Dietetic Association, June 2010

AIM: To evaluate the effects of ginger on gastric motility and emptying, abdominal symptoms, and hormones that influence motility in dyspepsia.

METHODS: Eleven patients with functional dyspepsia were studied twice in a randomized double-blind manner. After an 8-h fast, the patients ingested three capsules that contained ginger (total 1.2 g) or placebo, followed after 1 h by 500 mL low-nutrient soup. Antral area, fundus area and diameter, and the frequency of antral contractions were measured using ultrasound at frequent intervals, and the gastric half-emptying time was calculated from the change in antral area. Gastrointestinal sensations and appetite were scored using visual analog questionnaires, and blood was taken for measurement of plasma glucagon-like peptide-1 (GLP-1), motilin and ghrelin concentrations, at intervals throughout the study.

RESULTS: Gastric emptying was more rapid after ginger than placebo [median (range) half-emptying time 12.3 (8.5-17.0) min after ginger, 16.1 (8.3-22.6) min after placebo, P <= 0.05]. There was a trend for more antral contractions (P = 0.06), but fundus dimensions and gastrointestinal symptoms did not differ, nor did serum concentrations of GLP-1, motilin and ghrelin.

CONCLUSION: Ginger stimulated gastric emptying and antral contractions in patients with functional dyspepsia, but had no impact on gastrointestinal symptoms or gut peptides.

Purpose of review: For over a decade, the importance of zinc in the treatment of acute diarrhea has been recognized.

More recently, the mechanisms of action of zinc are becoming clearer. This review is focused on the new evidence on the mechanisms of action of zinc in acute diarrhea.

Recent findings: The vast majority of data derive from in-vitro studies using intestinal cell lines or from animal model. The positive action by zinc in acute diarrhea derives from a regulation of intestinal fluid transport, mucosal integrity, immunity, gene expression, and oxidative stress. A complex homeostatic network is also able to regulate zinc status at cellular and extracellular level.

Summary: All these data support the use of zinc in the treatment of acute diarrhea, but further clinical studies are needed to explore the selective effects of zinc against specific pathogens responsible for diarrhea.

ScienceDaily (Apr. 20, 2011) — University of Adelaide researchers have shown for the first time how peppermint helps to relieve Irritable Bowel Syndrome, which affects up to 20% of the population.

In a paper published in the journal Pain, researchers from the University's Nerve-Gut Research Laboratory explain how peppermint activates an "anti-pain" channel in the colon, soothing inflammatory pain in the gastrointestinal tract.

Dr Stuart Brierley says while peppermint has been commonly prescribed by naturopaths for many years, there has been no clinical evidence until now to demonstrate why it is so effective in relieving pain.

"Our research shows that peppermint acts through a specific anti-pain channel called TRPM8 to reduce pain sensing fibres, particularly those activated by mustard and chilli. This is potentially the first step in determining a new type of mainstream clinical treatment for Irritable Bowel Syndrome (IBS)," he says.

IBS is a gastrointestinal disorder, causing abdominal pain, bloating, diarrhea and/or constipation. It affects about 20% of Australians and costs millions of dollars each year in lost productivity, work absenteeism and health care.

"This is a debilitating condition and affects many people on a daily basis, particularly women who are twice as likely to experience Irritable Bowel Syndrome," Dr Brierley says.

"Some people find their symptoms appear after consuming fatty and spicy foods, coffee and alcohol, but it is more complex than that. There appears to be a definite link between IBS and a former bout of gastroenteritis, which leaves nerve pain fibres in a heightened state, altering mechanisms in the gut wall and resulting in ongoing pain."

Dr Brierley says the recent floods in Queensland and Victoria could result in a spike of gastroenteritis cases in Australia due to the contamination of some water supplies in affected regions.

He said case studies in Europe and Canada showed that many people who contracted gastroenteritis from contaminated water supplies went on to experience IBS symptoms that persisted for at least eight years.

There is no cure for IBS and it often comes and goes over a person's lifetime.

Apart from gastroenteritis and food intolerance, IBS can be brought on by food poisoning, stress, a reaction to antibiotics, and in some cases is genetic.

Dr Brierley is one of 25 researchers who work at the University of Adelaide's Nerve-Gut Research Laboratory, hoping to find cures and treatments for a range of intestinal diseases.

Story Source:

The above story is reprinted (with editorial adaptations by ScienceDaily staff) from materials provided by University of Adelaide.

Probiotic pills ease irritable bowel syndrome and other stomach problems more effectively than yogurt with probiotics, a recent survey of Consumer Reports subscribers suggests. Probiotics are helpful bacteria that naturally occur in the intestines. Other recent research concluded that probiotics, in yogurt or pills, might also help prevent colds.

In the Consumer Reports survey, 1,019 people said they took probiotic supplements to ease their stomach problems and 1,121 people said they consumed yogurt with lactobacillus acidophilus, a common probiotic. A third of the supplement users said the probiotic helped a lot, compared with 17 percent and 20 percent of those who consumed the yogurt for their IBS or another digestive disorder, respectively. Among people who used probiotics for their general health, those who took pills were more likely than those who consumed yogurt to get probiotics on all or most days.

Respondents said that neither supplements nor yogurt worked as well as prescription drugs.

The analysis on probiotics and colds, published this month by the Cochrane Collaboration, looked at 10 previous studies including 3,451 children and adults age 40 and younger who took pills or consumed yogurt for more than a week. It concluded that people who took a probiotic experienced 12 percent fewer acute upper respiratory tract infections over the study periods than those who took a placebo. In addition, people who took probiotics were less likely to need antibiotics to treat bacterial complications of those infections.

The researchers said that probiotics might help the immune system by bolstering gut wall integrity.

Bottom line: Neither our survey nor the new Cochrane analysis proves that probiotics protect the stomach or prevent colds, though they add to a growing a body of evidence suggesting they might. The survey of Consumer Reports subscribers, who may not be representative of the general population, differs from clinical trials, which has a control group and monitors dosing. Probiotics are safe for most people, though possible side effects include vomiting and flatulence. And you might need to avoid them if you’re pregnant or nursing, have a serious acute or chronic illness, or have weakened immunity, check with your doctor.

The number needed to treat to prevent one case of diarrhea from antibiotic use was just 13, they reported in the May 9 issue of the Journal of the American Medical Association.

Antibiotics lead to diarrhea in as many as 30% of patients, which is an important cause of nonadherence to the drugs.

"Potentially, probiotics maintain or restore gut microecology during or after antibiotic treatment through receptor competition, competition for nutrients, inhibition of epithelial and mucosal adherence of pathogens, introduction of lower colonic pH favoring the growth of nonpathogenic species, stimulation of immunity, or production of antimicrobial substances," the group suggested.

Most of the evidence, though, has accrued in adult trials almost universally underpowered to show the kind of impact seen in Hempel's analysis.

The meta-analysis included 82 randomized controlled trials, 57 of which used Lactobacillus-based interventions alone or in combination with other genera of probiotics (32 with Bifidobacterium). All but two trials used probiotics to prevent rather than treat existing antibiotic-associated diarrhea.

The effect on diarrhea risk could be pooled from 63 of the trials, with a total of 11,811 participants, and remained significant at P<0.001 when excluding any individual trial.

The trials where Lactobacillus probiotics was used exclusively were associated with reduced risk of antibiotic-associated diarrhea, similar to that in the overall analysis (pooled RR 0.64, P=0.004), with a number needed to treat of 14.

The 16 trials using only yeast as the probiotic, such as Saccharomyces boulardii [cerevisiae] or Hansen CBS 5926, also showed significantly reduced risk of antibiotic-associated diarrhea with a pooled relative risk of 0.48 (P<0.001) and number needed to treat of 10.

The researchers also looked for Streptococcus, Enterococcus, and Bacillus probiotic studies but found few.

Pooled results from three older trials using Enterococcus [Streptococcus] faecium SF68 showed a relative risk of 0.51 (P<0.001) and a number needed to treat of 12.

The difference between the different probiotic types wasn't significant (P=0.45) and didn't appear to explain away heterogeneity. Nor did the head-to-head comparison trials point to a clear winner.

The exact strains of the probiotic bugs used, though, were poorly documented, Hempel's group cautioned.

The analysis turned up no evidence of publication bias; no difference in probiotic treatment effect by conflict of interest status of the trials; and similar findings looking only at double-blind trials, or only at those with placebo control.

In addition to unexplained heterogeneity among included trials and poorly documented probiotics, limitations of the study included lack of information from experts about published or unpublished studies.

"Determining which populations would benefit most from adjunct probiotics therapy is an ongoing challenge; it must be considered that antibiotic-associated diarrhea does not occur in the majority of patients and when it occurs, it is usually self-limiting," Hempel's group wrote.

Little data was available on probiotic-specific adverse events. In rare cases reported decades ago, serious adverse effects like fungemia and bacterial sepsis were reported with probiotics, the researchers noted.

The RAND Corporation internally funded the review, building on the literature database established for a contracted evidence report on the safety of probiotics commissioned by the Agency for Healthcare Research and Quality, and funded jointly by the National Institutes of Health and the FDA Center for Food Safety and Applied Nutrition.

Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco.

Action Points

Manipulating the microbial flora within the intestine offers great promise for preventing or treating obesity and bowel disorders, but the precise means are not yet available. Note that initial data for stool transplant are promising with very high response rates in patients with recurrent C. difficile infections.

NEW ORLEANS -- Manipulating the microbial flora within the intestine offers great promise for preventing or treating obesity and bowel disorders, but the precise means are not yet available, a researcher said here.

It's clear that the diverse communities of microorganisms living in the human gut are necessary to normal health, and that their derangement can lead to metabolic and gastrointestinal disorders, said Walter Coyle, MD, of the Scripps Clinic in La Jolla, Calif.

By the same token, then, it ought to be possible to alter the makeup of those communities, either to forestall development of such disorders or to treat them when they do occur, he told attendees at the American College of Physicians' annual meeting.

However, the science of the intestinal "microbiome" is still in its infancy and it remains unclear what changes to make, let alone how best to make them, Coyle said.

For starters, the mix of gut flora varies greatly between individuals. Coyle cited results of a study of three members of the same household, whose intestinal bacterial composition differed markedly.

Although environmental influences clearly help direct how an intestinal bacterial community will evolve, host factors probably also play a role. Despite the explosion in genetic research over the past 20 years, "host genetic influences [on the gut microbiome] remain unexplored," Coyle said.

One reason to suppose that host factors are important is that, after a person reaches adulthood, he or she usually has a characteristic "core" population of intestinal bacteria that remains stable even in the face of disruptions such as antibiotic treatment.

Coyle described a recent line of research in this area that may yield a new approach to obesity.

Two major categories of bacteria dominate in the intestine: Firmicutes and Bacteroidetes. Studies have found that obese people tend to have a higher ratio of the former to the latter.

One clinical study of 12 people eating a calorie-restricted diet for one year found that there was no weight loss until the ratio of Firmacutes to Bacteroidetes shifted.

Coyle said that it was compelling data, but cautioned that it didn't mean that simply killing the Firmacutes would lead to weight loss. It remains unknown whether metabolic changes drove the change in gut flora or the reverse, he said.

What is clear, however, is that certain microbial communities in the intestine are more efficient than others at harvesting energy from food and making it available to the human host.

He cited studies showing that gut microbes may contribute 100 to 200 calories daily to the human host.

A relatively inefficient community would be less able to contribute to weight gain and could even induce weight loss, Coyle suggested.

But consumers and the medical community are not waiting for a complete understanding of the gut microbiome and its relation to health and disease -- efforts to manipulate the microbiome are well underway, via probiotics, prebiotics, and fecal transplants.

Probiotics are now firmly entrenched and Coyle said he recommends them routinely to patients with irritable bowel disorders.

He noted that data from randomized, controlled trials are scant and difficult to interpret because of methodological variations. For irritable bowel syndrome, the best data point to a reduction in gurgling noises and bloating, with more mixed results in constipation and/or diarrhea endpoints.

Some studies with particular preparations have shown benefit against recurrent C. difficile diarrhea.

"The data are more and more compelling that we should probably be [giving probiotics] to all hospital patients," Coyle said, citing a 2007 study in which only five or six patients had to be treated to prevent one case of diarrhea.

Probiotics were shown to be helpful in ulcerative colitis in a trial, although only in patients who followed the study protocol rigorously. Many patients had no benefit, but there was "a dramatic effect" in others, Coyle said.

Also gaining popularity are prebiotics -- various types of fiber that act as fertilizer for certain types of intestinal microbes. Some breakfast cereals now boast them on their packages, although the frequent side effect of flatulence is not mentioned.

Coyle said the ideal obesity treatment, which has not yet appeared, could be a prebiotic that promotes a microbial mix with a lower "energy harvest" in the intestine.

Another more direct method for altering the gut microbiome is through fecal transplants. These are the only direct way to artificially boost anaerobic species, which make up about 99.9% of gut bacteria, according to Coyle.

At this point, most clinical studies have been case series involving diarrheal diseases. The initial data are promising, Coyle said, with very high response rates in patients with recurrent C. difficile infections.

To the extent that the gut microbiome helps drives obesity, fecal transplants could become a treatment approach.

Some early tests have been performed in animals, Coyles said. For example, germ-free but otherwise normal mice receiving stool from genetically fat mice showed greater weight gain compared with normal mice with wild-type flora.

That study did not test whether fat mice would lose weight after receiving stool from a thin animal, however, and whether artificially altering the gut microbiome in humans will lead to weight loss or gain remains speculative.

Coyle reported consulting or speaking fees from Takeda and CSA Medical, but declared that he had no financial relationships with companies selling probiotics or prebiotics.

(dailyRx News) The pain and inconvenience of irritable bowel syndrome (IBS) can be made worse by not knowing how to prevent or treat a flare-up. Many doctors believe that IBS results from changes in bacteria in the colon. They also believe that managing this bacteria can help ease symptoms.

A recent small study investigates the use of a probiotic treatment to balance colon bacteria in patients with IBS.

The use of the probiotic treatment was shown to benefit the study participants with IBS."Ask your doctor about probiotic supplements and foods."

Sixty participants with IBS were randomly assigned to either receive the probiotic treatment or a placebo in the double blind study conducted by Shusheng Cui of the Hunagpu District Center Hospital in Shanghai, China and Ying Hu of the Xinghua Hospital at the University of Jiaotong in Shangai, China.

The 37 participants in the probiotic group ingested two of the capsules three times a day and the 23 participants in the placebo group ingested 200 mg of placebo capsule a day. The participants ingested the capsules for a total of four weeks.

Study participants completed questionnaires to determine IBS symptoms at the beginning of the study and at the end of the study.

Both groups of participants were similar in age, gender, bowel habit, symptoms and IBS severity.

Fecal samples were collected from the probiotic group at the beginning and end of the study. The placebo group submitted a fecal sample at the beginning of the study only.

DNA was taken from the fecal samples and analyzed for microbial content.

At the end of the study, a significant difference was seen between the two groups in time, frequency of pain, abdominal bloating and bowel habit satisfaction.

The probiotic group showed an effective rate of 64.86 percent on symptom reduction. The placebo group showed an effective rate of 30.43 percent.

As expected, the presence of Bifidobacterium and Lactobacillus bacteria were significantly greater at the end of the study than at the beginning in the probiotic group.

Deborah Gordon, MD, and CEO of DrDeborahMD.com suggests IBS patients increase their ingestion of probiotics through food sources like aged cheese, sauerkraut, kefir and kombucha. Use of supplements is a valid option if the food sources are not viable for the individual.

“It has been well studied that people with inflammatory bowel disease have disordered gut flora and that treatment with varied probiotics and prebiotics can be helpful in disease management and treatment,” Dr. Gordon said.

The study suggest that future studies should focus on identifying the mechanisms that make probiotics successful.

The study was published in the June issue of the International Journal of Clinical and Experimental Medicine.

Irritable bowel syndrome (IBS) is one of the most common functional gastrointestinal disorder which is associated with considerable sufferings of patient and Peppermint oil is volatile oil, its active principle is menthol-contain a cyclic monoterpine which has anti-spasmotic properties due to its ability to block calcium channel of intestinal smooth muscles. This study observed the efficacy of peppermint oil for relieving the symptoms and changes of quality of life (QOL) in diarrhea predominant IBS. This was a prospective double blind randomized placebo-controlled study conducted in the Bangabandhu Sheikh Mujib Medical University during July 2008 to September 2009. Patients who fulfilled ROME II were initially selected but those had red flag signs or any organic disease was excluded from the study. Seventy four patients were enrolled in the study and randomly allocated to receive either peppermint oil or placebo three times daily for six weeks. Changes of symptoms were assessed three week interval during treatment and two weeks after the end of treatment. Data were analyzed by paired and unpaired 't' test. Finally sixty five patients completed the trial. It was observed that, at six weeks of therapy abdominal pain is markedly improved (mean±SD) 4.94±1.30 in peppermint oil group compared with 6.15±1.24 in placebo group and the difference was statistically highly significant (p>0.001). But two weeks after end of trials pain score again increased (6.09±1.93). Other symptoms and quality of life did not improve significantly. So the study result concludes that peppermint oil is effective in reliving only abdominal pain in diarrhea predominant IBS transiently.

Herbal remedies, particularly peppermint, have been reported to be helpful in controlling symptoms of irritable bowel syndrome (IBS). We conducted a randomized double-blind placebo-controlled study on 90 outpatients with IBS. Subjects took one capsule of enteric-coated, delayed-release peppermint oil or placebo three times daily for 8 weeks. We visited patients after the first, fourth, and eighth weeks and evaluated their symptoms and quality of life. The number of subjects free from abdominal pain or discomfort changed from 0 at week 0 to 14 at week 8 in the peppermint group and from 0 to 6 in controls (P < 0.001). The severity of abdominal pain was also reduced significantly in the peppermint group as compared to controls. Furthermore, peppermint significantly improved the quality of life. There was no significant adverse reaction. Peppermint oil capsules are effective and safe as a therapeutic agent in patients with IBS suffering from abdominal pain or discomfort.

Research Scholar, Maternal and Child Health, Babol University of Medical Sciences and Health Services, Iran.Abstract

The aim of this study was to determine the clinical effect of Foeniculum vulgare on primary dysmenorrhoea. Sixty virgin girls with complaints of dysmenorrhoea were enrolled in this study, out of which 50 cases were completed the course of treatment and were divided in two groups (study and placebo) and were under treatment for two cycles. In study group a capsule of 30 mg fennel extract, four times a day for three days from start of their menstrual period and in placebo a capsule containing wheat flour in same dose was administered. Intensity of pain was reported by using a 10 - point linear analogue technique. In study group the mean age of menarche was 13.1 ± 0.1 and onset age of dysmenorrhoea was 14.5 ± 0.1 years. Both groups were relieved but there was significant difference between study and placebo group. Study group shown more effective results than placebo in pain relief (P`0.05). Based on the observations, it can be concluded that, fennel is an effective herbal drug for menstrual pain.KEYWORDS:

Background. Irritable bowel syndrome (IBS) is a chronic, difficult to treat condition. The efficacy of Aloe vera in treating IBS symptoms is not yet proven. The purpose of this study was to determine if Aloe vera is effective in improving quality of life. Methods. A multicentre, randomised, double-blind, cross-over placebo controlled study design. Patients were randomised to Aloe vera, wash-out, placebo or placebo, washout, Aloe vera. Each preparation (60&#8201;mL) was taken orally twice a day. Patient quality of life was measured using the Gastrointestinal Symptoms Rating Score, Irritable Bowel Syndrome Quality of Life, EuroQol and the Short-Form-12 at baseline and treatment periods 1 and 2. Results. A total of 110 patients were randomised, but only 47 completed all questionnaires and both study arms. Statistical analysis showed no difference between the placebo and Aloe vera treatment in quality of life. Discussion. This study was unable to show that Aloe vera was superior to placebo in improving quality of life. Drop outs and other confounding factors may have impacted on the power of the study to detect a clinically important difference. Conclusion. This study failed to find Aloe vera superior to placebo in improving quality of life proven Irritable Bowel Syndrome patients.

Aloe vera (AV) is suggested to be beneficial in treating irritable bowel syndrome (IBS) symptoms, but no scientific trials exist to confirm this. We aim to assess the efficacy of AV on IBS in refractory secondary care patients. Patients with IBS were randomised to receive AV or matching placebo for a month. Symptoms were assessed at baseline, 1 and 3 months. Fifty-eight patients randomised, 49 completed the protocol to 1 month and 41 to 3 months. Eleven of thirty-one (35%) AV patients, and 6 of 27 (22%) placebo patients responded at 1 month (p = 0.763). Diarrhoea predominant patients showed a trend towards a response to treatment at 1 month (10/23 V 2/14, p = 0.07). There was no evidence that AV benefits patients with IBS. However, we could not rule out the possibility that improvement occurred in patients with diarrhoea or alternating IBS whilst taking AV. Further investigations are warranted in patients with diarrhoea predominant IBS, in a less complex group of patients.

BOCA RATON, Fla., April 5, 2017 /PRNewswire/ -- A recently published case-controlled study, entitled "Vitamin D status in pediatric irritable bowel syndrome,"1 found more than 90 percent of pediatric patients with Irritable Bowel Syndrome (IBS) were deficient in vitamin D. According to the lead study author from UMass Memorial Health Care, Benjamin U. Nwosu, M.D., these children "are definitely at risk for decreased bone mass." The study was published on February 13, 2017, in PLOS ONE, a peer-reviewed, open-access scientific journal published by the Public Library of Science (PLOS), which covers primary research within science and medicine.

Dr. Nwosu said that he "was surprised that IBS had the highest prevalence of vitamin D deficiency of all gastrointestinal disorders we have studied in the past 5 years."

The study authors noted, "There is a much higher prevalence of vitamin D deficiency (in IBS) compared to IBD (Inflammatory Bowel Disease) and other malabsorption syndromes."

"Clinicians should immediately increase their surveillance for vitamin D deficiency in patients with IBS and initiate appropriate vitamin D supplementation in cases of deficiency," said Dr. Nwosu.

Vitamin D Deficiency in Adults With IBSA previous analysis in adults conducted with patients with IBS and a healthy control group without IBS, entitled "Vitamin D Deficiency in Patients with Irritable Bowel Syndrome: Does it Exist?"2, showed that vitamin D deficiency was highly prevalent in patients with IBS, and that vitamin D supplementation should be considered as part of the therapeutic protocol in patients with IBS. The 2015 study was published in the Oman Medical Journal, a peer-reviewed, open-access international journal.

Yasir Khayyat, M.D., the lead study author, concluded that vitamin D supplementation could play a therapeutic role in control of IBS. He said, "With an enhanced attention on the role of vitamin D deficiency in the pathogenesis of several chronic illnesses, deficiency of vitamin D in IBS has recently caught the interest of medical professionals. There have been numerous attempts of therapeutic application of vitamin D to improve IBS symptoms. More research is needed to establish the therapeutic role of vitamin D in the management of IBS patients and deficiency should be addressed in the diagnosis and the treatment of the condition."

Another double-blind, placebo-controlled pilot study recently was conducted by the University of Sheffield (U.K.). This study of adults with IBS, entitled "Vitamin D associates with improved quality of life in participants with irritable bowel syndrome: outcomes from a pilot trial,"3 showed that 78 percent of the IBS patients in the study were vitamin D deficient, and, at baseline, circulating vitamin D levels were correlated with IBS patients' quality of life. The lead author of the study, Simon Tazzyman, M.D., hypothesized that vitamin D supplementation may improve IBS symptoms. Study results revealed that vitamin D supplementation significantly improved vitamin D levels in both the placebo and vitamin D supplementation arms. However, in this study, the two arms did not separate when it came to IBS symptoms' severity. The 2016 study was published in the BMJ Open Gastroenterology, an online-only, peer-reviewed open access gastroenterology journal, dedicated to publishing high-quality medical research from all disciplines and therapeutic areas of gastroenterology.

Peppermint oil has been used for centuries as a treatment for gastrointestinal ailments. It has been shown to have several effects on gastrointestinal physiology relevant to clinical care and management.Aim

To review the literature on peppermint oil regarding its metabolism, effects on gastrointestinal physiology, clinical use and efficacy, and safety.Methods

We performed a PubMed literature search using the following terms individually or in combination: peppermint, peppermint oil, pharmacokinetics, menthol, oesophagus, stomach, small intestine, gallbladder, colon, transit, dyspepsia, nausea, abdominal pain, and irritable bowel syndrome. Full manuscripts evaluating peppermint oil that were published through 15 July 2017 were reviewed. When evaluating therapeutic indications, only randomised clinical trials were included. References from selected manuscripts were used if relevant.Results

It appears that peppermint oil may have several mechanisms of action including: smooth muscle relaxation (via calcium channel blockade or direct enteric nervous system effects); visceral sensitivity modulation (via transient receptor potential cation channels); anti-microbial effects; anti-inflammatory activity; modulation of psychosocial distress. Peppermint oil has been found to affect oesophageal, gastric, small bowel, gall-bladder, and colonic physiology. It has been used to facilitate completion of colonoscopy and endoscopic retrograde cholangiopancreatography. Placebo controlled studies support its use in irritable bowel syndrome, functional dyspepsia, childhood functional abdominal pain, and post-operative nausea. Few adverse effects have been reported in peppermint oil trials.Conclusion

Peppermint oil is a natural product which affects physiology throughout the gastrointestinal tract, has been used successfully for several clinical disorders, and appears to have a good safety profile.